Medical Policy

Policy Num:       07.001.146
Policy Name:     Discectomy
Policy ID:          [07.001.146]  [Ac / L / M+ / P-]  [ 7.01.18  and 7.01.146]

Last Review:       October 24, 2024
Next Review:      October 20, 2025
 

Related Policies:

07.001.058 - Artificial Intervertebral Disc: Cervical Spine
07.001.042 - Percutaneous Intradiscal Electrothermal Annuloplasty, Radiofrequency Annuloplasty, and Biacuplasty
07.001.065 - Artificial Intervertebral Disc: Lumbar Spine
07.001.005 - Decompression of the Intervertebral Disc Using Laser Energy (Laser Discectomy) or Radiofrequency-Coblation (Nucleoplasty)
08.001.006 - Vertebral Axial Decompression

Discectomy

Summary

Discectomy is a surgical procedure in which one or more intervertebral discs are removed. Extrusion of an intervertebral disc beyond the intervertebral space can compress the spinal nerves and result in pain, numbness, and weakness. Discectomy is intended to treat symptoms by relieving pressure on the affected nerve root(s). Discectomy can be performed by a variety of surgical approaches, with either open surgery or minimally invasive techniques.

For individuals who have lumbar herniated disc(s) and symptoms of radiculopathy rapidly progressing or refractory to conservative care who receive lumbar discectomy, the evidence includes randomized controlled trials (RCT) and systematic reviews. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. In patients with lumbar radiculopathy with disc herniation who receive discectomy, there is sufficient evidence to support the use of discectomy in patients who have not responded to “usual care” for 6 weeks. The evidence is limited by a lack of high-quality trials. In most trials, a high percentage of patients in the conservative care group crossed over to surgery. This high degree of crossover reduced the power to detect differences when assessed by intention-to-treat analysis. Analysis by treatment received was also flawed because of the potential noncomparability of groups resulting from the high crossover rate. Despite the methodologic limitations, the evidence has consistently demonstrated a probable short-term benefit for surgery and a more rapid resolution of pain and disability. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have cervical herniated disc(s) and symptoms of radiculopathy rapidly progressing or refractory to conservative care who receive cervical discectomy, the evidence includes 2 RCTs, a long-term observational study, and a systematic review. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. There is considerably less evidence on cervical discectomy than on lumbar discectomy. The best evidence on the efficacy of cervical discectomy consists of 2 small RCTs comparing discectomy with conservative care, and a systematic review of these trials. Although there is less evidence for this indication, it does not differ substantially from lumbar herniated disc, showing that patient-reported symptoms and disability favor surgery in the short-term, and that long-term outcomes do not differ. Because cervical discectomy closely parallels lumbar discectomy, with close similarities in anatomy and surgical procedure, it can be inferred that the benefit reported for lumbar discectomy supports a benefit for cervical discectomy. Based on the available evidence and extrapolation from studies of lumbar herniated disc, it is likely that use of discectomy for cervical herniated disc improves short-term symptoms and disability. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have herniated intervertebral disc(s) who receive automated percutaneous discectomy, the evidence includes randomized controlled trials (RCTs) and systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The published evidence from small RCTs is insufficient to evaluate the impact of automated percutaneous discectomy on the net health outcome. Well-designed and executed RCTs are needed to determine the benefits and risks of this procedure. Clinical input suggests this intervention may be an appropriate treatment option for the highly selected patient who has a small focal disc fragment compressing a lumbar nerve causing radiculopathy in the absence of lumbar stenosis or severe bony foraminal stenosis.  Clinical Input suggests may be medically necessary for a selected group of patients.

For individuals who have herniated intervertebral disc(s) who receive percutaneous endoscopic discectomy, the evidence includes a number of RCTs and systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Many of the more recent RCTs are conducted at institutions within China. There are few reports from the United States. Results do not reveal a consistently significant improvement in patient-reported outcomes and treatment-related morbidity with percutaneous endoscopic discectomy in comparison to other discectomy interventions. Clinical input suggests this intervention may be an appropriate treatment option for the highly selected patient who has a small focal disc herniation causing lumbar radiculopathy according to clinical input expert opinion. Clinical input suggests may be medically necessary for a selected group of patients.

Objective

The objective of this evidence review is to determine whether the use of discectomy improves the net health outcome for individuals with lumbar or cervical herniated discs that are progressing or refractory to conservative care compared with conservative nonsurgical care.

Policy Statements

Lumbar discectomy 

• Traditional approach (open)

• Automated percutaneous discectomy

• Automated endoscopic discectomy

(see Policy Guidelines section) may be considered medically necessary for the treatment of lumbar herniated disc when the following criteria are met:

• Signs and symptoms of radiculopathy on history and physical exam (see Policy Guidelines section).

• One of the following clinical presentations is present:

  • Rapidly progressing neurologic deficits; OR

  • Persistent debilitating back or leg pain that is refractory to at least 6 weeks of conservative therapy (see Policy Guidelines section).

• Documentation of nerve root compression on imaging (magnetic resonance imaging or computed tomography) at a level that corresponds with the patient's symptoms (see Policy Guidelines section).

Lumbar discectomy is not medically necessary for the treatment of lumbar herniated disc when the above criteria are not met.

Cervical discectomy

• Traditional approach (open)

• Automated percutaneous discectomy

• Automated endoscopic discectomy

(see Policy Guidelines section) may be considered medically necessary for the treatment of cervical herniated disc when the following criteria are present:

• Signs and symptoms of radiculopathy and/or myelopathy on history and physical exam (see Policy Guidelines section).

• One of the following clinical presentations is present:

  • Rapidly progressing neurologic deficits; OR

  • Persistent debilitating neck, back, or arm pain that is refractory to at least 6 weeks of conservative therapy (see Policy Guidelines section); OR

  • Persistent or progressive symptoms of myelopathy that are refractory to at least 6 weeks of conservative therapy (see Policy Guidelines section).

• Documentation of nerve root compression on imaging (magnetic resonance imaging or computed tomography) at a level that corresponds with the patient's symptoms (see Policy Guidelines section).

Cervical discectomy is not medically necessary for the treatment of cervical herniated disc when the above criteria are not met.

Discectomy is considered investigational for all other indications.

Policy Guidelines

Lumbar Discectomy

Lumbar discectomy refers to standard open discectomy or minimally invasive microdiscectomy. Microdiscectomy will be defined for the purpose of this evidence review as having the following features: (1) uses a small surgical incision (as opposed to an endoscopic "port"), (2) uses a specially designed microscope to achieve direct visualization of the vertebral column (as opposed to indirect visualization with an endoscope or other type of cameras), and (3) removes disc and other surgical products by direct visualization through the surgical incision. Microdiscectomy may be done with adjunctive devices, such as tubular retractors to improve visualization, or endoscopy to localize the correct areas to operate. However, removal of the disc itself must be done under direct visualization to be considered microdiscectomy.

Cervical Discectomy

Cervical discectomy refers to open anterior cervical discectomy (with or without fusion) or minimally invasive posterior cervical discectomy/foraminotomy.

Minimally invasive techniques

Minimally invasive techniques percutaneous/endoscopic discectomy (manual or automated). Removal of bulging disc is performed through the endoscope.

There are numerous alternative procedures for performing discectomy, with uncertain efficacy compared with standard procedures. For this evidence review, the following procedures, most of which are discussed in other policies, are considered investigational:

• Laser discectomy (evidence review 7.01.93)

• Radiofrequency coblation (nucleoplasty) (evidence review 7.01.93)

• Intradiscal electrothermal annuloplasty (evidence review 7.01.72)

• Intradiscal radiofrequency therapy (evidence review 7.01.72)

• Chemonucleolysis

Radiculopathy

Radiculopathy presents with a characteristic set of signs and symptoms based on history and physical exam.

History:

• Pain that radiates down the back of the leg to below the knee

• Numbness and tingling in a dermatomal distribution

• Muscular weakness in a pattern associated with spinal nerve root compression.

Physical exam:

• Positive straight leg raise test

• Loss of deep tendon reflexes corresponding to affected nerve root level

• Loss of sensation in a dermatomal pattern.

Conservative nonsurgical therapy for the duration specified should include the following:

• Use of prescription-strength analgesics for several weeks at a dose sufficient to induce a therapeutic response

  • Analgesics should include anti-inflammatory medications with or without adjunctive medications, such as nerve membrane stabilizers or muscle relaxants, AND

• Participation in at least 6 weeks of physical therapy (including active exercise) or documentation of why the patient could not tolerate physical therapy, AND

• Evaluation and appropriate management of associated cognitive, behavioral, or addiction issues AND

• Documentation of patient compliance with the preceding criteria.

Persistent debilitating pain is defined as:

• Significant level of pain on a daily basis, defined on a visual analog scale score as greater than 4; AND

• Pain on a daily basis that has a documented impact on activities of daily living despite optimal conservative nonsurgical therapy, as outlined above, and appropriate for the patient.

Medical Necessity

Medical necessity is established by documentation of medical history, physical findings, and diagnostic imaging results that demonstrate spinal nerve compression and support the surgical treatment intervention. Documentation in the medical record must clearly support the medical necessity of the surgery and include medical history, physical examination, and diagnostic testing.

Medical History

• Assessment of comorbid physical and psychological health conditions (eg, morbid obesity, current smoking, diabetes, renal disease, osteoporosis, and severe physical deconditioning)

• History of back surgery, including minimally invasive back procedures

• Prior trial, failure, or contraindication to conservative medical/nonoperative interventions that may include but are not limited to the following:

• • Activity modification for at least 6 weeks

  • Oral analgesics and/or anti-inflammatory medications

  • Physical therapy

  • Chiropractic manipulation

  • Epidural steroid injections.

Physical Examination

• Clinical findings including the patient's stated symptoms and duration.

Diagnostic Testing

• Radiologically confirmed lumbar spine abnormality based on a magnetic resonance image or computerized tomography scan with myelogram of the lumbar spine within the past 6 months

• Report of the selective nerve root injection results, if applicable to the patient's diagnostic workup.

Coding

Please see the Codes table for details.

Benefit Application

BlueCard/National Account Issues - None.

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered.  Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

Background

Disc Herniation

Extrusion of an intervertebral disc beyond the intervertebral space can compress the spinal nerves and result in symptoms of pain, numbness, and weakness.

The natural history of untreated disc herniations is not well-characterized, but most herniations will decrease in size over time due to shrinking and/or regression of the disc.^1, Clinical symptoms will also tend to improve over time in conjunction with shrinkage or regression of the herniation.

Treatment

Because most disc herniations improve over time, initial care is conservative, consisting of analgesics and a prescribed activity program tailored to patient considerations. Other potential nonsurgical interventions include opioid analgesics and chiropractic manipulation. Epidural steroid injections can also be used as a second-line intervention and are associated with short-term relief of symptoms.^2,

However, some disc herniations will not improve over time with conservative care. A small proportion of patients will have rapidly progressive signs and symptoms, thus putting them at risk for irreversible neurologic deficits. These patients are considered to be surgical emergencies, and expedient surgery is intended to prevent further neurologic deterioration and allow for nerve recovery.

Other patients will not progress but will have the persistence of symptoms that require further intervention. It is estimated that up to 30% of patients with sciatica will continue to have pain for more than 1 year.^3, For these patients, there is a high degree of morbidity and functional disability associated with chronic back pain, and there is a tendency for recurrent pain despite treatment. Therefore, treatments that have more uniform efficacy for patients with a herniated disc and chronic back pain are needed. In particular, decreased chronic pain and decreased disability are the goals of treatment of chronic low back pain due to a herniated disc.

Surgical Treatment

Discectomy is a surgical procedure in which one or more intervertebral discs are removed. The primary indication for discectomy is herniation (extrusion) of an intervertebral disc. Discectomy is intended to treat symptoms by relieving pressure on the affected nerve(s).

Lumbar Discectomy

Lumbar discectomy can be performed by a variety of surgical approaches. Open discectomy is the traditional approach. In open discectomy, a 2- to 3-cm incision is made over the area to be repaired. The spinal muscles are dissected, and a portion of the lamina may be removed to allow access to the vertebral space. The extruded disc is removed either entirely or partially using direct visualization. Osteophytes that are protruding into the vertebral space can also be removed if deemed necessary.

The main alternative to open discectomy is microdiscectomy, which has gained popularity. Microdiscectomy is a minimally invasive procedure that involves a smaller incision, visualization of the disc through a special camera, and removal of disc fragments using special instruments. Because less resection can be performed in a microdiscectomy, it is usually reserved for smaller herniations, in which a smaller amount of tissue needs to be removed. A few controlled trials comparing open discectomy with microdiscectomy have been published and reported that neither procedure is clearly superior to the other, but that microdiscectomy is associated with more rapid recovery. ^4,; ^5,Systematic reviews and meta-analyses have also concluded that the evidence does not support the superiority of 1 procedure over another.^6,7,8,

Cervical Discectomy

The most common procedure for cervical discectomy is anterior cervical discectomy. This is an open procedure in which the cervical spine is approached through an incision in the anterior neck. Soft tissues and muscles are separated to expose the spine. The disc is removed using direct visualization. This procedure can be done with or without spinal fusion, but most commonly it is performed with fusion.

A less invasive procedure for cervical discectomy is posterior cervical discectomy and foraminotomy. This is performed through a small incision in the back of the neck. The nerves and muscles are separated using a small retractor. The spine is visualized with microscopic guidance, and a portion of the spine-the foramen-is removed to expose the spinal canal. Special instruments are used to remove a portion of the disc or the entire disc.

Adverse Events

Complications of discectomy generally include bleeding, infections, and inadvertent nerve injuries. Dural puncture occurs in a small percentage of patients, leading to leakage of cerebrospinal fluid that can be accompanied by headaches and/or neck stiffness. In a small percentage of cases, worsening of neurologic symptoms can occur postsurgery.

Other Surgical Alternatives

Other variations on discectomy include the following. These procedures do not have high-quality comparative trials vs standard discectomy, and will therefore not be considered as true alternatives to discectomy for this evidence review:

• Laser discectomy

• Radiofrequency coblation (nucleoplasty)

• Intradiscal electrothermal annuloplasty

• Intradiscal radiofrequency therapy

• Vertebral axial decompression

• Chemonucleolysis.

LUMBAR DISC PROLAPSE

The purpose of surgery for symptomatic lumbar disc prolapse is to relieve symptoms due to inflammation of, or pressure on, affected nerve roots by removing part of, or the entire, disc.

A variety of discectomy techniques are available:

●The traditional open discectomy is performed with a standard surgical incision, often with the aid of eyepiece (loupe) magnification. It frequently involves a laminectomy (removal of the vertebral lamina to relieve pressure on nerve roots).

●Microdiscectomy, a refinement of open discectomy, has become the most common procedure and can be performed on an outpatient basis. It involves a smaller incision in the back, with visualization through an operating microscope, followed by a hemilaminectomy (removal of part of the lamina in order to adequately visualize the disc) and removal of the disc fragment compressing the affected nerve or nerves.

●Minimally invasive techniques include percutaneous manual nucleotomy, percutaneous discectomy, laser discectomy, endoscopic discectomy, microendoscopic discectomy, and radiofrequency nucleoplasty . Tubular or trochar discectomy is a less invasive technique in which a tubular retractor is inserted over a guidewire, gaining access to the disc by muscle splitting rather than muscle incision and detachment .

Minimally invasive techniques involve smaller incisions and surgery with the aid of indirect visualization; some techniques employ lasers to vaporize parts of the disc or automated techniques for removing portions of the disc. They have the potential advantage of quicker recovery from surgery compared with standard open discectomy or microdiscectomy.

Major postoperative complications are rare for any of the discectomy procedures .

Standard open discectomy or microdiscectomy

Compared with no surgery — Randomized trials comparing surgery to nonsurgical management for lumbar disc prolapse with persistent radiculopathy indicate that patients who undergo surgery experience faster and larger improvements, though substantial improvements are observed regardless of whether patients undergo surgery or not and in some studies outcomes appear similar within two years. The available randomized trials have not been blinded (which can only be accomplished by performing sham surgical procedures) and thus are likely to be influenced by a patient's expectations of treatment results.

An early trial comparing surgery with nonsurgical therapy for lumbar disc prolapse with nerve root compression found one-year outcome superior for standard open discectomy, with a lower likelihood of poor results (odds ratio [OR] 0.37, 95% CI 0.14-0.99); differences were no longer present after 4 to 10 years. One-quarter of patients randomized to nonsurgical therapy eventually underwent surgery, making longer-term results difficult to interpret.

The Spine Patient Outcomes Research Trials (SPORT) are multicenter, randomized trials, with associated prospective cohort studies, evaluating surgery versus nonsurgical therapy for three spinal conditions: lumbar disc herniation, spinal stenosis without degenerative spondylolisthesis, and spinal stenosis with degenerative spondylolisthesis [43]. The SPORT trial of surgery for prolapsed lumbar disc found standard open discectomy or microdiscectomy (technique left to discretion of the surgeon) no better than nonoperative treatment for pain relief and improvement in function after three months, in an intention-to-treat analysis. Patients in both groups improved an average of 20 to 30 points (on a 100 point scale) on pain and functional status scores. Results up to four and eight years showed persistent, comparable benefits for surgical and nonoperative treatment in an intention-to-treat analysis for the study primary outcomes of bodily pain, physical function, and disability index. Secondary outcomes (sciatica bothersomeness, self-rated improvement, and patient satisfaction with symptoms) were better for the group assigned to surgery. These results likely underestimate the relative benefit of surgical treatment, since about half of patients assigned to either arm crossed over to the other intervention.

A concurrent prospective cohort study of SPORT patients who met eligibility criteria but declined randomization reported moderate benefits at three months through two years for surgical treatment, compared with nonoperative treatment (10 to 15 points on the 0 to 100 SF-36 bodily pain scale; 12 to 15 points on the 0 to 100 SF-36 physical function scale; 2 to 4 points on the 0 to 24 Sciatica Bothersomeness Index), after adjusting for potential confounders. These results were similar to those of an on-treatment analysis of the randomized trial. A combined analysis at four and eight years included all patients from the randomized trial and observation cohort who underwent surgery and compared them with patients who had nonsurgical care. Patients who had surgery for lumbar disc herniation, compared with those who did not undergo surgery, had greater improvement for all outcomes evaluated (pain, functional status, and disability indices) other than work status.

An earlier long-term (up to 10 years) cohort study also found early benefits from discectomy that became attenuated with longer follow-up. As with all observational studies, interpretation of these results should take into account the possibility of confounding due to factors contributing to the patients' choice of treatment, expectations from treatment, and perception of symptoms.

A cost-effectiveness analysis using SPORT data from 775 surgical patients and 416 nonoperative patients (on-treatment analysis of randomized trial and observational cohorts) found that surgery, compared with nonoperative care, resulted in higher costs but better health outcomes at two years. The cost per quality-adjusted life year (QALY) gained with surgery ranged from USD $34,000 to $69,000, depending on imputed surgical costs, and was comparable with other commonly accepted health care interventions. The cost per QALY gained with surgery decreased when reevaluated at four years, indicating increasing value for surgery, compared with nonoperative management with longer follow-up.

Two randomized trials compared outcomes for early microdiscectomy or initial nonsurgical treatment in patients with lumbar disc herniation and radicular pain lasting 6 to 12 weeks. In both trials, about 40 percent of patients assigned to initial nonsurgical treatment underwent surgery.

●In the larger trial (n = 283), 125 patients underwent microdiscectomy at a mean of 2.2 weeks; 55 of the 142 patients assigned to conservative therapy had surgery at a mean of 19 weeks. There was no difference in disability scores after one year between the group assigned to early surgery or conservative treatment. Patients assigned to surgery reported a faster rate of perceived recovery (hazard ratio [HR] 1.97, 95% CI 1.72-2.22). A concurrent cost utility analysis found surgery likely to be cost-effective from a societal perspective. Early surgery was associated with increased QALY and negligible costs compared with nonsurgical therapy after factoring in costs saved by early productivity.

Perceived recovery at one year for both groups was 95 percent. Patient satisfaction decreased for both groups with longer term follow-up. At two-year follow-up, there was no difference in patient reports of unsatisfactory outcomes (20 percent) or disability scores between the two groups.

●A smaller (n = 58) randomized trial found no difference between microdiscectomy and nonsurgical therapy (isometric exercises) on any outcome after two years; microdiscectomy was moderately superior for leg pain at six weeks and trends favored microdiscectomy at two years.

Guidelines from the American Pain Society recommend that clinicians discuss risks and benefits of surgery with patients who have persistent, disabling radiculopathy due to a herniated lumbar disc. Shared decision-making regarding surgery should be based on understanding that benefits are moderate on average and decrease over time compared with patients who do not choose to have surgery.

Comparing open discectomy with microdiscectomy — Microdiscectomy is performed with an operating microscope through a smaller incision than open discectomy and has become the standard surgical procedure for lumbar disc herniation. Four trials found no clear differences between standard open discectomy and microdiscectomy in patients with lumbar disc herniation and radiculopathy.

Minimally invasive procedures — Minimally invasive surgical approaches that utilize techniques to further reduce incision size and the area of dissection have been introduced as potential alternatives to standard open discectomy and microdiscectomy. Until more definitive evidence is available showing clear advantages for alternative surgical techniques, our preference is for standard microdiscectomy or open discectomy for patients with lumbar disc herniation and radiculopathy who are appropriate surgical candidates.

A 2014 review of 11 randomized or quasi-randomized trials suggested that, compared with open discectomy or microdiscectomy, minimally invasive procedures are associated with less surgical site infections, but they may be inferior for relief of leg and back pain and rehospitalization due to recurrent disc herniation. The minimally invasive procedures evaluated in the review were percutaneous endoscopic lumbar discectomy (eight trials), transmuscular tubular microdiscectomy (two trials), and automated percutaneous discectomy (one trial).

Other trials have evaluated other minimally invasive procedures:

●One small (n = 62) trial compared percutaneous disc decompression to conservative therapy (medications, physical therapy, education, counseling) [57]. Percutaneous disc decompression was associated with higher pain scores at three months (3.0 versus 0.9 on a 0 to 10 scale), but lower pain scores at one year (1.6 versus 4.0) and at two years (1.7 versus 4.0). Challenges in interpreting this trial are that it used an inadequate randomization method (alternate allocation), and it is unclear why decompression would have a delayed effect, as most trials have shown that benefits of discectomy are most pronounced at short-term follow-up.

●A randomized but unblinded trial in one center compared standard microdiscectomy and simple fragment excision (microscopic sequestrectomy, a procedure in which disc fragments are removed without entering the disc space itself) in 84 patients with single-level disc herniation and no prior surgery [58]. Both groups improved substantially immediately following surgery. At two-year follow-up, rates of reherniation between the groups did not differ, while self-reported motor function improved over time for the sequestrectomy group, and worsened for the microdiscectomy group. Longer-term outcomes and confirmation of these findings by additional studies are needed before the limited procedure can be routinely recommended.

There are no published trials comparing other minimally invasive techniques (eg, laser-assisted discectomy) versus open discectomy, microdiscectomy, or nonsurgical therapy.

Regulatory Status

Discectomy is a surgical procedure and, as such, is not subject to regulation by the U.S. Food and Drug Administration. Some instrumentation used during laminectomy may be subject to U.S. Food and Drug Administration approval.

The Dekompressor® Percutaneous Discectomy Probe (Stryker), Herniatome Percutaneous Discectomy Device (Gallini Medical Devices), and the Nucleotome® (Clarus Medical) are examples of percutaneous discectomy devices that have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The FDA indication for these products is for "aspiration of disc material during percutaneous discectomies in the lumbar, thoracic and cervical regions of the spine." FDA product code: HRX.

A variety of endoscopes and associated surgical instruments have also been cleared for marketing by FDA through the 510(k) process.

Rationale

This evidence review was created in October 2014 and has been updated regularly with searches of the PubMed database. The most recent literature update was performed through April 22, 2022.

Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function. Every clinical condition has specific outcomes that are important to patients and to managing the course of the condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of the change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials are rarely large or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Population Reference No. 1 

Lumbar Discectomy

Clinical Context and Therapy Purpose

The purpose of lumbar discectomy in patients who have lumbar herniated disc(s) and symptoms of radiculopathy rapidly progressing or refractory to conservative care is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: Does lumbar discectomy improve the net health outcome in patients with lumbar herniated disc(s) and symptoms of radiculopathy rapidly progressing or refractory to conservative care?

The following PICO was used to select literature to inform this review.

Patients

The relevant population of interest is patients who have lumbar herniated disc(s) and symptoms of radiculopathy rapidly progressing or refractory to conservative care.

Extrusion of an intervertebral disc beyond the intervertebral space can compress the spinal nerves and result in symptoms of pain, numbness, and weakness.

Interventions

The therapy being considered is lumbar discectomy.

Lumbar discectomy can be performed by a variety of surgical approaches. Open discectomy is the traditional approach. In open discectomy, a 2- to 3-cm incision is made over the area to be repaired. The spinal muscles are dissected, and a portion of the lamina may be removed to allow access to the vertebral space. The extruded disc is removed either entirely or partially using direct visualization. Osteophytes that are protruding into the vertebral space can also be removed if deemed necessary.

Comparators

The following therapies and practices are currently being used to make decisions about lumbar discectomy.

Because most disc herniations improve over time, initial care is conservative, consisting of analgesics and a prescribed activity program tailored to patient considerations. Other potential nonsurgical interventions include opioid analgesics and chiropractic manipulation. Epidural steroid injections can also be used as a second-line intervention and are associated with short-term relief of symptoms.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, health status measures, quality of life, treatment-related mortality, and treatment-related morbidity.

Outcome measures for back surgery are relatively well-established (see Table 1). Most studies used back and leg visual analog scores (VAS) or the Zurich Claudication Questionnaire to assess pain and the Oswestry Disability Score (ODI) to assess functional limitations related to back pain. Most studies also use a broader functional status index such as the Short Form (SF)-12 or SF-36, particularly the physical function subscale of SF-36. Throughout this report, we refer to a combination of pain and function measures as “Back and Leg Pain Measures.” Determining the minimal clinically important differences (MCID) for these measures is complex. The MCID for a given measure can depend on the baseline score or severity of illness, the method used to calculate MCID, and the times at which the scores are measured.^9, For these reasons, some investigators prefer to calculate a minimum detectable difference (MDD).^10,

Both short- and long-term outcomes are important in evaluating back treatments.^11, For example, for definitive back surgery, net benefit should take into account immediate (perioperative) adverse events; improvements in pain, neurological status, and function at 12 to 24 months as measured by the ODI, SF-36, Zurich Claudication Questionnaire, or visual analog scale measures; and 5-year secondary surgery rates, which reflect longer-term complications, recurrences, and treatment failures. On the other hand, epidural injections are intended to provide quick, short-term relief from pain. The net benefit of epidural injections should emphasize effectiveness in relieving symptoms for weeks to months. Less important, but still relevant outcomes are the frequency of sustained response and the eventual need for surgery.

Patient preferences are important in decision-making about elective back surgery. In particular, to avoid the morbidity and risk of complications of the surgery, some patients may choose to prolong conservative treatments even if it means they have additional pain and functional limitation. Conversely, some patients will accept long-term outcomes of surgery similar to those of conservative therapy to get faster relief of symptoms and improvement in function.

In some trials, the epidural injection has been considered an event indicative of treatment failure. This is usually not appropriate. Instead, patient-reported outcomes should be measured at prespecified time intervals in all patients, whether or not they undergo injections or secondary procedures. When possible, trials should use explicit criteria for secondary surgeries or measure patient-reported outcomes just prior to secondary procedures so those implicit criteria for reoperation can be compared across studies.

Table 1. Patient-reported Outcome Measures for Back and Leg Pain

 MDD: minimal detectable difference; MCID: minimal clinically important difference; RMDQ: Roland and Morris Disability Questionnaire.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs and systematic review of RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess longer term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

Review of Evidence

Systematic Reviews

Recent systematic reviews confirm that discectomy improves patient-reported outcomes but disagree about the duration of the effect.

A very comprehensive systematic review and meta-analysis of 7 RCTs published between 1983 and 2017 concluded that, at 6 months, surgery reduced mean VAS-leg pain scores by 6 to 26 points more than conservative interventions; the evidence was mixed for ODI scores, the Roland and Morris Disability Questionnaire, and the SF-36 Physical Functioning subscale.^12, Surgery and nonsurgical interventions produced similar improvements in quality of life, neurologic symptoms, and return to work. No between-group differences were observed at 1 year or later. A limitation of this review is that it considered only the intention-to-treat analyses of the Spine Patient Outcomes Research Trial (SPORT) trial and similar trials. The as-treated analysis of the SPORT trial found persistently better outcomes for surgery in up to 8 years of follow-up.

Clark et al (2020) published a systematic review assessing the efficacy, safety, and cost of surgical versus nonsurgical management of lumbar radiculopathy.^13, The systematic review included 7 RCTs (N=1158) published between January 2007 and April 2019; 5 of these RCTs utilized discectomy and/or microdiscectomy as the surgical intervention for lumbar radiculopathy. Percutaneous disc decompression with or without coblation technology was the surgical intervention performed in the remaining 2 RCTs. Results were similar to the Washington State Health Care Authority review^12, and revealed that surgery reduced VAS-leg pain scores as compared to nonsurgical management at up to week 26; however, the differences in these scores did not persist at 1 year or later. Regarding function and disability, the evidence was mixed with minimal differences between surgical and nonsurgical management at 2 years. Comparable improvements in quality of life, neurologic symptoms, and return to work were seen with no surgical deaths and infrequent surgical morbidity reported. The authors of the systematic review rated 5 included RCTs as having a high risk of bias due to inadequate methods of randomization or allocation concealment, lack of blinding, crossover, and attrition.

Another comprehensive systematic review and meta-analysis of 8 RCTs and 6 prospective cohort studies found that over 1 to 5 years of follow-up, compared with conservative treatment, lumbar discectomy reduced leg pain by 10 points on the VAS-leg pain scale and back pain by 7 points on the VAS-back pain scale.^7,

Randomized Controlled Trials

Following the systematic reviews noted above, Bailey et al (2020) published a prospective RCT from a single Canadian site involving 128 patients with persistent sciatica lasting 4 to 12 months and lumbar disc herniation.^14, Enrolled patients were randomly assigned to undergo microdiscectomy or receipt of 6 months of standardized nonoperative care (education regarding day-to-day functioning, activity and exercise, oral analgesics, active physiotherapy, epidural glucocorticoid injections) followed by surgery if necessary. Follow-up was performed at 6 weeks, 3 months, 6 months, and 1 year after enrollment. Results revealed that the surgical group experienced a significant reduction in the VAS-leg pain intensity score at 6 months as compared to the nonsurgical group. At 1 year, a continued reduction in leg-pain intensity, as well as ODI score and pain, was observed in the surgical group. There was a potential impact on external validity with this trial as both surgeons and patients may have been less inclined to undertake nonsurgical care if severe sciatica was present. Additionally, the generalizability of this study may be diminished due to its single-center nature and up to 20% of the data for the primary outcome were absent, leading to the use of multiple imputation. Of note, 22 patients from the nonsurgical group ultimately crossed over to surgery due to intractable sciatic pain.

Section Summary: Lumbar Discectomy

For individuals who have lumbar herniated disc(s) and symptoms of radiculopathy refractory to conservative care who receive lumbar discectomy, the evidence includes a recent RCT and systematic reviews. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. In patients with lumbar radiculopathy with disc herniation who receive discectomy, there is sufficient evidence to support the use of discectomy in patients who have not responded to “usual care” for 6 weeks, but the net benefit is uncertain because of the lack of a robust RCT comparing discectomy with a comprehensive conservative treatment program. The evidence is limited by a lack of high-quality trials. In most trials, a high percentage of patients in the conservative care group crossed over to surgery. This high degree of crossover reduced the power to detect differences when assessed by intention-to-treat analysis. Analysis by treatment received was also flawed because of the potential noncomparability of groups resulting from the high crossover rate. Despite the methodologic limitations, the evidence has consistently demonstrated a probable short-term benefit for surgery and a more rapid resolution of pain and disability. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Summary of Evidence

For individuals who have lumbar herniated disc(s) and symptoms of radiculopathy rapidly progressing or refractory to conservative care who receive lumbar discectomy, the evidence includes randomized controlled trials (RCT) and systematic reviews. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. In patients with lumbar radiculopathy with disc herniation who receive discectomy, there is sufficient evidence to support the use of discectomy in patients who have not responded to “usual care” for 6 weeks. The evidence is limited by a lack of high-quality trials. In most trials, a high percentage of patients in the conservative care group crossed over to surgery. This high degree of crossover reduced the power to detect differences when assessed by intention-to-treat analysis. Analysis by treatment received was also flawed because of the potential noncomparability of groups resulting from the high crossover rate. Despite the methodologic limitations, the evidence has consistently demonstrated a probable short-term benefit for surgery and a more rapid resolution of pain and disability. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Population Reference No. 2 

Cervical Discectomy

Clinical Context and Therapy Purpose

The purpose of cervical discectomy in patients who have cervical herniated disc(s) and symptoms of radiculopathy rapidly progressing or refractory to conservative care is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: Does cervical discectomy improve the net health outcome in patients with cervical herniated disc(s) and symptoms of radiculopathy rapidly progressing or refractory to conservative care?

The following PICO was used to select literature to inform this review.

Patients

The relevant population of interest is patients who have cervical herniated disc(s) and symptoms of radiculopathy rapidly progressing or refractory to conservative care.

Extrusion of an intervertebral disc beyond the intervertebral space can compress the spinal nerves and result in symptoms of pain, numbness, and weakness.

Interventions

The therapy being considered is cervical discectomy.

The most common procedure for cervical discectomy is anterior cervical discectomy. This is an open procedure in which the cervical spine is approached through an incision in the anterior neck. Soft tissues and muscles are separated to expose the spine. The disc is removed using direct visualization. This procedure can be done with or without spinal fusion, but most commonly it is performed with fusion.

A less invasive procedure for cervical discectomy is posterior cervical discectomy and foraminotomy. This is performed through a small incision in the back of the neck. The nerves and muscles are separated using a small retractor. The spine is visualized with microscopic guidance, and a portion of the spine-the foramen-is removed to expose the spinal canal. Special instruments are used to remove a portion of the disc or the entire disc.

Comparators

The following therapies and practices are currently being used to make decisions about cervical discectomy.

Because most disc herniations improve over time, initial care is conservative, consisting of analgesics and a prescribed activity program tailored to patient considerations. Other potential nonsurgical interventions include opioid analgesics and chiropractic manipulation. Epidural steroid injections can also be used as a second-line intervention and are associated with short-term relief of symptoms.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, health status measures, quality of life, treatment-related mortality, and treatment-related morbidity.

Both short-term and long-term outcomes are important in evaluating discectomy. Net benefit should take into account immediate (perioperative) adverse events; improvements in pain, neurological status, and function at 12 to 24 months as measured by the ODI, SF-36, Zurich Claudication Questionnaire, or VAS measures; and 5-year secondary surgery rates, which reflect longer-term complications, recurrences, and treatment failures.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs and systematic review of RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess longer term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

Review of Evidence

Systematic Reviews

A Cochrane systematic review by Nikolaidis et al (2010) included 2 RCTs.^15,Only one of the trials specifically recruited patients with cervical radiculopathy; this RCT is discussed more fully below.^16, Reviewers judged both trials in the Cochrane review to have a significant risk of bias due to inadequate allocation concealment and unclear blinding of outcomes assessment. Reviewers concluded that there was low-quality evidence for a short-term benefit of surgery, with an uncertain risk-benefit ratio for surgery. The reviewers also found no evidence for a long-term benefit of surgery.

Randomized Controlled Trials

Persson et al (1997), compared surgery with conservative care in 81 patients who had longstanding cervical radiculopathy.^16, Patients were randomized to surgery or 1 of 2 control groups: an active exercise program or use of a cervical collar. Outcome measures included a VAS for pain (range, 0-100), muscle strength in the upper extremities, and sensation in the upper extremities. Follow-up time points were at 4 and 12 months. Three patients in the surgery group declined surgery because of improvement in symptoms, and there were no crossovers from conservative care to surgery. At the 4-month follow-up, the surgery group had less sensory loss and better muscle strength. By 1-year, there were no group differences on any of the main outcomes.

Peolsson et al (2013) published a multicenter RCT from Sweden after publication of the 2010 systematic review in which 63 patients with cervical disc disease (verified by magnetic resonance imaging) were randomized to structured exercise alone or structured exercise with cervical discectomy.^17, The surgical procedure consisted of anterior cervical decompression with fusion. Follow-up was at 3, 6, 12, and 24 months. During the trial, there were 2 crossovers from the exercise group to surgery. At the 2-year follow-up, there were no significant differences on any of the main outcomes. There were improvements in both groups on multiple measures of functional status over time, but these improvements do not differ significantly between groups. This trial did not assess any outcomes for pain or disability.

Observational Studies

Faught et al (2016) published results from a telephone interview evaluating the long-term outcomes among a cohort of patients (N=338) who underwent posterior cervical foraminotomies.^18, Each interview collected information on symptomatic and functional improvements postsurgery. The EuroQol-5D, a standardized instrument to measure health-related quality of life, was also administered. Mean follow-up was 10 years. Ninety-three percent of patients who could not work before surgery were able to return to work. As measured by the EuroQol-5D, patients reported: "no problems" in mobility (65%), self-care (90%), usual activities (60%), pain (41%), and anxiety/depression (77%).

Section Summary: Cervical Discectomy

For individuals who have cervical herniated disc(s) and symptoms of radiculopathy rapidly progressing or refractory to conservative care who receive cervical discectomy, the evidence includes 2 RCTs, a long-term observational study, and a systematic review. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. There is considerably less evidence on cervical discectomy than on lumbar discectomy. The best evidence on the efficacy of cervical discectomy consists of 2 small RCTs comparing discectomy with conservative care, and a systematic review of these trials. Although there is less evidence for this indication, it does not differ substantially from lumbar herniated disc, showing that patient-reported symptoms and disability favor surgery in the short-term, and that long-term outcomes do not differ. Because cervical discectomy closely parallels lumbar discectomy, with close similarities in anatomy and surgical procedure, it can be inferred that the benefit reported for lumbar discectomy supports a benefit for cervical discectomy. Based on the available evidence and extrapolation from studies of lumbar herniated disc, it is likely that use of discectomy for cervical herniated disc improves short-term symptoms and disability. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Summary of Evidence

For individuals who have cervical herniated disc(s) and symptoms of radiculopathy rapidly progressing or refractory to conservative care who receive cervical discectomy, the evidence includes 2 RCTs, a long-term observational study, and a systematic review. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. There is considerably less evidence on cervical discectomy than on lumbar discectomy. The best evidence on the efficacy of cervical discectomy consists of 2 small RCTs comparing discectomy with conservative care, and a systematic review of these trials. Although there is less evidence for this indication, it does not differ substantially from lumbar herniated disc, showing that patient-reported symptoms and disability favor surgery in the short-term, and that long-term outcomes do not differ. Because cervical discectomy closely parallels lumbar discectomy, with close similarities in anatomy and surgical procedure, it can be inferred that the benefit reported for lumbar discectomy supports a benefit for cervical discectomy. Based on the available evidence and extrapolation from studies of lumbar herniated disc, it is likely that use of discectomy for cervical herniated disc improves short-term symptoms and disability. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Population Reference No. 3 

Automated Percutaneous Discectomy

Clinical Context and Therapy Purpose

The purpose of automated percutaneous discectomy in patients who have herniated intervertebral disc(s) is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: Does the use of automated percutaneous discectomy improve the net health outcome in individuals with herniated intervertebral disc(s)?

The following PICO was used to select literature to inform this review.

Patients

The relevant population of interest is individuals with herniated intervertebral disc(s).

Interventions

The therapy being considered is automated percutaneous discectomy.

Percutaneous discectomy is provided in a hospital setting with specialized staff, equipped to perform the surgical procedure and postsurgical care.

Comparators

The following therapies and practices are currently being used to treat herniated intervertebral disc(s): conservative therapy and open discectomy or microdiscectomy.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Specific outcomes measured by specific instruments may include improvements in functional outcomes assessed on the Oswestry Disability Index (ODI), reductions in pain using a visual analog scale (VAS), improvements in quality of life measured on the 36-Item Short-Form Health Survey (SF-36) and Euro-QOL-5D, and treatment-related morbidity including surgical success/failure and complications. To assess outcomes, follow-up at 1 year is considered appropriate.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

1. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

2. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

3. To assess longer term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

Review of Evidence

Systematic Reviews

Systematic reviews have assessed automated percutaneous discectomy compared to other interventions; however, the majority of these reviews contained observational studies published more than a decade ago with generally small patient populations and inconsistent results. Lewis et al (2015) published the most recent systematic review and network meta-analysis comparing trials of 21 different treatment strategies for sciatica.^1,Examples of the 21 treatment strategies included in the analysis include conservative care, disc surgery, intraoperative interventions, epidural injections, biologic agents, and percutaneous discectomy. Under the category of "percutaneous discectomy," reviewers combined automated percutaneous discectomy, percutaneous automated nucleotomy, nucleoplasty, and laser discectomy. They searched 28 databases and trial registries through December 2009. Ninety studies were included and 10 involved the percutaneous discectomy category as an intervention. Of the 10, 4 are relevant to this evidence review: 2 case-control studies of percutaneous endoscopic discectomy (2006, 2007), 1 RCT of percutaneous endoscopic discectomy (1993), and 1 RCT of automated percutaneous discectomy (1995). The remaining studies were published in a foreign language or involved other comparators (nucleolysis, chemonucleolysis). The global effects odds ratio for the category of percutaneous discectomy compared with inactive control was 0.82 (95% confidence interval, 0.39 to 1.72), which was inferior to disc surgery, epidural injections, and intraoperative interventions. The pain intensity weighted mean difference for the category of percutaneous discectomy compared with inactive control was 11.5 (95% confidence interval, -18.6 to 41.6). Reviewers concluded that there was no support for the effectiveness of percutaneous discectomy for the treatment of sciatica. Due to the inclusion of additional interventions into the broad category of percutaneous discectomy in this review, the relevance of these results to this evidence review is limited.

Randomized Controlled Trials

The 2002 Lumbar Automated Percutaneous Discectomy Outcomes Group(LAPDOG) trial is the most recent RCT to compare automated percutaneous discectomy with open discectomy in patients with lumbar disc herniation.^2, No additional RCTs have been identified since the 2002 LAPDOG trial. The trial was designed to recruit 330 patients but enrolled 36 patients for reasons not readily apparent. Twenty-seven patients were available at follow-up, with efficacy reported by 41% of those undergoing automated percutaneous discectomy and by 40% of those undergoing conventional discectomy. The trialists concluded that "It is difficult to understand the remarkable persistence of percutaneous discectomy in the face of a virtually complete lack of scientific support for its effectiveness in treated lumbar disc herniation." The tables below more fully describe key characteristics, results, and limitations of the LAPDOG trial.

Table 1. Characteristics of the LAPDOG Trial

 LAPDOG: Lumbar Automated Percutaneous Discectomy Outcomes Group; NR: not reported.

Table 2. Results of the LAPDOG Trial

 LAPDOG: Lumbar Automated Percutaneous Discectomy Outcomes Group; NR: not reported. aSuccess was defined as either an excellent or good result as defined by an outcome matrix. bFailure was defined as not achieving success or requiring a second procedure during the follow-up period.

Table 3. Study Relevance Limitations of the LAPDOG Trial

 LAPDOG: Lumbar Automated Percutaneous Discectomy Outcomes Group;  aPopulation key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use. bIntervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4.Not the intervention of interest. cComparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively. dOutcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported. eFollow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 4. Study Design and Conduct Limitations of the LAPDOG Trial

 aAllocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias. bBlinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician. cSelective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication. dData Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials). ePower key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power fStatistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.

All published trials have focused on lumbar disc herniation. There were no RCTs of automated percutaneous discectomy for cervical or thoracic disc herniation. A review of the evidence from American Society of Interventional Pain Physicians (2013) noted that "even though Dekompressor [disc removal system] may be considered a new interventional modality, the early studies were published approximately 8 years ago. Consequently, one would expect that the technique's continued use would be supported by more recent, high-quality evaluations."^3,

Section Summary: Automated Percutaneous Discectomy

The evidence for automated percutaneous discectomy in individuals who have herniated intervertebral disc(s) includes small RCTs and systematic reviews. Evidence from small RCTs does not support the use of this procedure. Well-designed and executed RCTs are needed to determine the benefits and risks of this procedure. Clinical input suggests this intervention may be an appropriate treatment option for the highly selected patient who has a small focal disc fragment compressing a lumbar nerve causing radiculopathy in the absence of lumbar stenosis or severe bony foraminal stenosis. However, the clinical input is not generally supportive of a clinically meaningful improvement in net health outcome. Further details from clinical input are included in the Clinical Input section later in the review and the Appendix.

Clinical Input Responses

• "Automated percutaneous lumbar discectomy is an appropriate treatment option for the highly selected patient who has a small focal disc fragment compressing a lumbar nerve causing radiculopathy in the absence of lumbar stenosis or severe bony foraminal stenosis. The success rate is less than for traditional lumbar discectomy at 75%, and is less effective in patients with free fragments or stenosis. This procedure should be performed only by surgeons who are appropriately trained in both percutaneous and open lumbar surgery." (AANS/CNS)

• "There does not appear to be sufficient evidence to support the clinical use of automated percutaneous lumbar discectomy for individuals with herniated intervertebral disc(s)." (NASS & AAOS)

• "We don't use this technology or method at our institution and don't believe it is superior to alternative approaches." (Anonymous, Neurosurgery, identified by an academic medical center)

Population Reference No. 4 

Percutaneous Endoscopic Discectomy

Clinical Context and Therapy Purpose

The purpose of percutaneous endoscopic discectomy in patients who have herniated intervertebral disc(s) is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: Does the use of percutaneous endoscopic discectomy improve the net health outcome in individuals with herniated intervertebral disc(s)?

The following PICO was used to select literature to inform this review.

Patients

The relevant population of interest is individuals with herniated intervertebral disc(s).

Interventions

The therapy being considered is percutaneous endoscopic discectomy.

Comparators

The following therapies and practices are currently being used to treat herniated intervertebral disc(s): conservative therapy and open discectomy or microdiscectomy.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Specific outcomes measured by specific instruments include improvements in functional outcomes assessed on the ODI, reductions in pain using a VAS, improvements in quality of life measured on the SF-36 and Euro-QOL-5D, and treatment-related morbidity including surgical success/failure and complications. To assess outcomes, follow-up at 1 year is considered appropriate.

Percutaneous endoscopic discectomy is provided in a hospital setting with specialized staff, equipped to perform the surgical procedure and postsurgical care.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess longer term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

Review of Evidence

Systematic Reviews

A number of systematic reviews have evaluated the efficacy and safety of percutaneous endoscopic discectomy to open discectomy or microendoscopic discectomy (MED). A comparison of the trials included in more recent systematic reviews (2016 to present) is shown in Table 5. The systematic reviews included a total of 46 trials published between 1993 and 2018. Characteristics and results of these reviews are summarized in Tables 6 and 7.

Table 5. Trials Included in Systematic Reviews of Percutaneous Endoscopic Discectomy Versus Other Discectomy Procedures

Table 6. Summary of Systematic Reviews of Percutaneous Endoscopic Discectomy Versus Other Discectomy Procedures

 FED: full-endoscopic technique discectomy; MED: microendoscopic discectomy; PELD: percutaneous endoscopic lumbar discectomy; PTED: percutaneous transforaminal endoscopic discectomy; RCT: randomized controlled trial

Table 7. Results of Systematic Reviews of Trials of Percutaneous Endoscopic Discectomy Versus Other Discectomy Procedures

 CI: confidence interval; NR: not reported; MD: mean difference; ODI: Oswestry Disability Index; OR: odds ratio; RR: risk ratio; VAS: visual analogue scale; WMD: weighted mean difference

Results from the systematic reviews were fairly consistent with a significantly reduced length of hospitalization observed with endoscopic discectomy and sometimes significant improvements in VAS or ODI, but only at specific time points. Overall, no consistently significant improvement in VAS, ODI, total complication rate, reoperation, or recurrence was observed with endoscopic discectomy versus other interventions. Authors of the systematic reviews noted multiple limitations including the innate flaws of included studies (ie, observational designs, a limited number of studies meeting criteria for inclusion, small sample sizes, lack of allocation concealment and blinding), different methodologies contributing to heterogeneity in analyses, loss of usable and sufficient data resulting in difficulty performing accurate analysis of outcomes, and that a majority of the more recently completed studies were completed in China, which may affect the generalizability of the results to other populations.

Randomized Controlled Trials

A total of 48 trials comparing percutaneous endoscopic discectomy to other discectomy procedures are included in this policy. Forty-six of these trials were included in at least 1 systematic review (Table 5). Two additional more recent RCTs not included in any of the systematic reviews were identified.^56,;^57, Results of these trials were similar to those seen in the more comprehensive systematic reviews - percutaneous endoscopic discectomy was associated with a significant reduction in length of stay with no consistent improvement in patient-reported outcome measures such as VAS and ODI. Additionally, the trials did not assess any treatment-related morbidities including overall complication, reoperation, and recurrence rates. Key characteristics, results, and limitations of these RCTs are summarized in the following tables.

Table 8. Characteristics of RCTs of Percutaneous Endoscopic Discectomy

Table 9. Results of RCTs of Percutaneous Endoscopic Discectomy

 ODI: Oswestry Disability Index; SF-36 PCS: Short-Form-36 Physical Component Score; VAS: visual analogue scale. aPostoperative patient-reported outcome measures at 2 years.

Table 10. Study Relevance Limitations of the RCTS of Percutaneous Endoscopic Discectomy

 aPopulation key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use. bIntervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4.Not the intervention of interest. cComparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively. dOutcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported. eFollow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 11. Study Design and Conduct Limitations of the RCTs of Percutaneous Endoscopic Discectomy

 aAllocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias. bBlinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician. cSelective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication. dData Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials). ePower key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power fStatistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.

Observational Studies

Gotecha et al (2016) published a prospective study on the use of transforaminal PELD for the treatment of lumbar disc herniation.^58, Efficacy and limitations of the procedure were studied in 120 patients with lumbar disc herniation. Using McNab criteria, 89% achieved excellent (no pain or restrictions) or good (occasional back/leg pain) status at 6 months of follow-up. The authors noted a limitation of the procedure is that during surgery on patients with L5 through S1 lumbar disc herniation, the iliac crest may interfere with the angle necessary to perform a successful discectomy.

A number of observational studies have also assessed the learning curve^59,60,61, and the need for longer follow-up for endoscopic discectomy.^62,63, The largest and longest follow-up to date has been reported by Choi et al (2015), who examined 10,228 patients at their institution who had had PELD over a 12-year period.^64, They found that 4.3% of cases required reoperation in the first 6 weeks due to incomplete removal of herniated discs (2.8%), recurrence (0.8%), persistent pain (0.4%), and approach-related pain (0.2%).

Section Summary: Percutaneous Endoscopic Discectomy

The evidence for percutaneous endoscopic discectomy in individuals who have herniated intervertebral disc(s) includes a number of RCTs and systematic reviews. Many of the more recent RCTs are conducted at institutions within China. There are few reports from the United States. Overall, results from RCTs and systematic reviews reveal a significantly reduced length of hospitalization with endoscopic discectomy and occasionally significant improvements in VAS or ODI, but only at specific time points. No consistently significant improvement in VAS, ODI, total complication rate, reoperation, or recurrence was observed with percutaneous endoscopic discectomy versus other interventions. Clinical input suggests this intervention may be an appropriate treatment option for the highly selected patient who has a small focal disc herniation causing lumbar radiculopathy according to clinical input expert opinion. However, respondents were mixed in the level of support of this indication, and overall there was not a preponderance of clinical input support in general cases. Further details from clinical input are included in the Clinical Input section later in the review and the Appendix.

Clinical Input Responses

• "Percutaneous endoscopic discectomy is a treatment option for patients who have a small focal disc herniation causing lumbar radiculopathy. It utilizes an endoscope that is placed through an image guided approach. It is only appropriate for patients in whom the pathology can be approached through an interlaminar approach, as it does not allow for any significant bone removal. Again, it should only be performed by surgeons who are facile and appropriately trained in this technique as well as open lumbar surgery." (AANS/CNS)

• "Although some studies report longer operative times, higher complication rates, and additional time for providers' to learn the technique, there is sufficient evidence to support clinical efficacy for percutaneous endoscopic discectomy for individuals with herniated intervertebral disc(s). Well conducted studies show equivalent or superior results compared to open microdiscectomy in terms of surgery time, hospital stay, return to work, patient satisfaction, and short as well as long term clinical results." (NASS & AAOS)

• "We don't use this technology or method at our institution. We aren't convinced that it is superior to an open or MIS procedure involving use of the microscope." (Anonymous, Neurosurgery, identified by an academic medical center)Supplemental Information

SUPPLEMENTAL INFORMATION

N/A

PRACTICE GUIDELINES AND POSITION STATEMENTS

North American Spine Society

In 2014, the North American Spine Society published evidence-based clinical guidelines on the diagnosis and treatment of lumbar disc herniation with radiculopathy.^1, Table 2 summarizes the recommendations specific to open discectomy or microdiscectomy.

Table 2. Recommendations for Treating Lumbar Disc Herniation With Radiculopathy

 GOR: grade of recommendation. a Grade B: fair evidence (level II or III studies with consistent findings); grade I: insufficient evidence.

In 2011, the North American Spine Society published evidence-based clinical guidelines on the diagnosis and treatment of cervical radiculopathy from degenerative disorders.^8, The guidelines included evaluations of anterior cervical discectomy (ACD), ACD with fusion, ACD with instrumented fusion, ACD with fusion plus plate, and posterior laminoforaminotomy. Recommendations are listed in Table 3.

Table 3. Recommendations Treating Cervical Radiculopathy from Degenerative Disorders

 ACD: anterior cervical discectomy; ACDF: anterior cervical discectomy with fusion; GOR: grade of recommendation; PLF: posterior laminoforaminotomy. a Grade B: fair evidence (level II or III studies with consistent findings); grade C: poor quality evidence (level IV or V studies).

International Society for the Advancement of Spine Surgery

In 2019, the International Society for the Advancement of Spine Surgery published a policy on the surgical treatment of lumbar disc herniation with radiculopathy.^19, This policy contained a review of available clinical evidence and concluded that discectomy (open, microtubular, or endoscopic) is a medically necessary procedure for the treatment of patients who do not respond to nonsurgical care or have severe and deteriorating symptoms. Per the policy, documentation requirements include confirmation of radiculopathy based on history/physical examination AND either the presence of disabling leg or back pain refractory to 6 weeks of conservative care or progressive neurologic deficit AND level appropriate documentation of nerve root compression on imaging and/or nerve conduction velocity/electromyogram.

U.S. Preventive Services Task Force Recommendations

Not applicable.

Medicare National Coverage

There is no national coverage determination. In the absence of a national coverage determination, coverage decisions are left to the discretion of local Medicare carriers.

References

1. Kreiner DS, Hwang SW, Easa JE, et al. An evidence-based clinical guideline for the diagnosis and treatment of lumbar disc herniation with radiculopathy. Spine J. Jan 2014; 14(1): 180-91. PMID 24239490
2. American Academy of Neurology (AAN). Use of epidural steroid injections to treat lumbosacral radicular pain. 2007; https://www.aan.com/Guidelines/Home/GetGuidelineContent/250. Accessed May 6, 2020.
3. Jacobs WC, van Tulder M, Arts M, et al. Surgery versus conservative management of sciatica due to a lumbar herniated disc: a systematic review. Eur Spine J. Apr 2011; 20(4): 513-22. PMID 20949289
4. Henriksen L, Schmidt K, Eskesen V, et al. A controlled study of microsurgical versus standard lumbar discectomy. Br J Neurosurg. Jun 1996; 10(3): 289-93. PMID 8799541
5. Katayama Y, Matsuyama Y, Yoshihara H, et al. Comparison of surgical outcomes between macro discectomy and micro discectomy for lumbar disc herniation: a prospective randomized study with surgery performed by the same spine surgeon. J Spinal Disord Tech. Jul 2006; 19(5): 344-7. PMID 16826006
6. Mu X, Wei J, Li P. What were the advantages of microendoscopic discectomy for lumbar disc herniation comparing with open discectomy: a meta-analysis?. Int J Clin Exp Med. 2015; 8(10): 17498-506. PMID 26770340
7. Arts MP, Kursumovic A, Miller LE, et al. Comparison of treatments for lumbar disc herniation: Systematic review with network meta-analysis. Medicine (Baltimore). Feb 2019; 98(7): e14410. PMID 30762743
8. Bono CM, Ghiselli G, Gilbert TJ, et al. An evidence-based clinical guideline for the diagnosis and treatment of cervical radiculopathy from degenerative disorders. Spine J. Jan 2011; 11(1): 64-72. PMID 21168100
9. Katz NP, Paillard FC, Ekman E. Determining the clinical importance of treatment benefits for interventions for painful orthopedic conditions. J Orthop Surg Res. Feb 03 2015; 10: 24. PMID 25645576
10. Parker SL, Mendenhall SK, Shau DN, et al. Minimum clinically important difference in pain, disability, and quality of life after neural decompression and fusion for same-level recurrent lumbar stenosis: understanding clinical versus statistical significance. J Neurosurg Spine. May 2012; 16(5): 471-8. PMID 22324801
11. Katz JN. Surgery for lumbar spinal stenosis: informed patient preferences should weigh heavily. Ann Intern Med. Apr 07 2015; 162(7): 518-9. PMID 25844999
12. Washington State Health Care Authority. Surgery for Lumbar Radiculopathy/ Sciatica. Final Evidence Report. Prepared by the RTI-UNC Evidence-based Practice Center. 2018. Available at: https://www.hca.wa.gov/assets/program/lumbar-radiculopathy-final-rpt-2180418.pdf. Accessed May 6, 2020.
13. Clark R, Weber RP, Kahwati L. Surgical Management of Lumbar Radiculopathy: a Systematic Review. J Gen Intern Med. Mar 2020; 35(3): 855-864. PMID 31713029
14. Bailey CS, Rasoulinejad P, Taylor D, et al. Surgery versus Conservative Care for Persistent Sciatica Lasting 4 to 12 Months. N Engl J Med. Mar 19 2020; 382(12): 1093-1102. PMID 32187469
15. Nikolaidis I, Fouyas IP, Sandercock PA, et al. Surgery for cervical radiculopathy or myelopathy. Cochrane Database Syst Rev. Jan 20 2010; (1): CD001466. PMID 20091520
16. Persson LC, Moritz U, Brandt L, et al. Cervical radiculopathy: pain, muscle weakness and sensory loss in patients with cervical radiculopathy treated with surgery, physiotherapy or cervical collar. A prospective, controlled study. Eur Spine J. 1997; 6(4): 256-66. PMID 9294750
17. Peolsson A, Soderlund A, Engquist M, et al. Physical function outcome in cervical radiculopathy patients after physiotherapy alone compared with anterior surgery followed by physiotherapy: a prospective randomized study with a 2-year follow-up. Spine. Feb 15 2013; 38(4): 300-7. PMID 23407407
18. Faught RW, Church EW, Halpern CH, et al. Long-term quality of life after posterior cervical foraminotomy for radiculopathy. Clin Neurol Neurosurg. Mar 2016; 142: 22-25. PMID 26802616
19. Lorio M, Kim C, Araghi A, et al. International Society for the Advancement of Spine Surgery Policy 2019-Surgical Treatment of Lumbar Disc Herniation with Radiculopathy. Int J Spine Surg. Feb 2020; 14(1): 1-17. PMID 32128297

20.  Subacute and chronic low back pain: Surgical treatment Author: Roger Chou, MD Section Editor: Steven J Atlas, MD, MPH Deputy Editor: Lisa Kunins, MD. UpToDate  Literature review current through: Oct 2020. | This topic last updated: Apr 23, 2020. 

Codes

Policy History