Herniation, or extrusion, of an intervertebral disc can compress the spinal nerves and result in symptoms of radiculopathy including pain, numbness, and weakness. The natural history of untreated disc herniations is not well characterized, but most will decrease in size over time due to shrinking and/or regression of the disc. In conjunction, clinical symptoms also tend to improve. Therefore, initial care often consists of conservative treatment, including rest, analgesics, and/or a prescribed activity program tailored to the individual. Cervical myelopathy often involves pain-related symptoms of the upper extremities and legs as well as bowel and bladder function. It results from disruption or interruption of normal neural transmission in the spinal cord and may be caused by degenerative processes including intervertebral disc herniation, inflammation, or tumors.
Depending on the cause of radiculopathy and/or myelopathy, symptoms may resolve over time with conservative treatment. A small proportion of individuals may have rapidly progressive signs or symptoms, which may involve risk for irreversible neurologic deficits. Other individuals may have persistent, but nonprogressive symptoms, which may require further intervention. For these individuals, there is a high degree of morbidity and functional disability associated with chronic back pain. Therefore, surgical treatment may also be considered.
Discectomy is a surgical procedure in which one or more intervertebral discs are removed. It is intended to treat symptoms associated with disc herniation, by relieving pressure on the affected nerve(s). Lumbar discectomy can be performed by a variety of surgical approaches. Open discectomy is the traditional approach, in which 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 may also be removed if necessary. An alternative to open discectomy is microdiscectomy. It is a minimally invasive procedure that involves a smaller incision, visualization by means of a special camera, and removal of disc fragments using specialized instruments. The amount of resection that can be performed during microdiscectomy is less; therefore, the procedure is typically reserved for small herniations.
Cervical discectomy is often performed with an anterior open approach, in which the cervical spine is accessed through an incision in the anterior neck. Soft tissue and muscle are separated to expose the spine. The disc is then removed using direct visualization. This procedure can be performed with or without spinal fusion, but is most commonly performed with fusion in a procedure known as anterior cervical discectomy and fusion (ACDF). Posterior cervical discectomy and foraminotomy is a less-invasive procedure performed through a small incision in the back of the neck. The nerves and muscle are separated using a small retractor and the spine is visualized with microscopic guidance, and a portion of the spine, known as the foramen, is removed to expose the spinal canal. Specialized instruments are used to remove a portion or the entire disc.
Spinal osteotomy procedures are reported when a portion or portions of the vertebral segment or segments are cut and removed in preparation for realigning the spine as part of a spinal deformity correction. These procedures may be required for congenital, developmental, and degenerative spinal deformities.
Corpectomy typically reflects a longitudinal resection of the vertebral body from disc space to disc space, often resulting in a destabilization of the complex. In the cervical spine, at least 50% of the vertebral body is removed and in the thoracic/lumbar spine, at least 30% of the corpus is removed.
An annular (annulus) repair/closure may be performed following a spinal decompression (discectomy) surgery. Discectomy procedures involve removal of a bony portion of the vertebral body to access the posterior side of the disc space, and removal of the impinging fragment from the disc. This fragment may be within the wall of the annulus, requiring incision into the annulus to remove it. An annular closure device (ACD) (e.g., Barricaid, Xclose Tissue Repair System, Disc Annular Repair Technology [DART] System, Inclose Surgical Mesh System), is implanted during a lumbar discectomy procedure to act as a barrier to block the annular defect and reduce herniation and reoperation. The annulus fibrosus has a limited healing capacity after an annulotomy and reherniation may result in a poor clinical outcome. A variety of surgical techniques designed to preserve, repair, or reinforce the annulus fibrosus following annulotomy are under study.
PEER-REVIEWED LITERATURE
In a prospective, randomized controlled trial (RCT), Buttermann (2004) evaluated the safety and effectiveness of epidural steroid injections when compared with standard discectomy in individuals with lumbar herniated nucleus pulposus. A total of 169 individuals with a large herniation (i.e., >25% of the cross-sectional area of the spinal canal) were followed over a 3-year period. Of these individuals, 100 participants who had no improvement after a minimum of 6 weeks of nonsurgical treatment were randomly assigned 1:1 to receive either epidural steroid injection (n=50) or surgical discectomy (n=50). Individuals who underwent discectomy had the most rapid decrease in symptoms, with up to 98% of participants reporting that the treatment had been successful. Up to 56% of the individuals who received an epidural steroid injection reported that the treatment had been effective. Those who did not obtain relief from the steroid injections had a subsequent discectomy and their outcomes did not appear to be have been adversely affected by the delay in surgery. The authors concluded that epidural steroid injections were not as effective as discectomy with respect to reducing symptoms and disability associated with a large herniation of the lumbar disc.
In a prospective observational cohort study (i.e., Spine Patient Outcomes Research Trial [SPORT]), Weinstein et al. (2006) compared the safety and effectiveness of standard open discectomy with nonsurgical treatment for individuals with lumbar disc herniation (LDH). Of the 743 individuals initially enrolled in the observational cohort, ultimately 528 individuals were treated with discectomy and 191 received nonsurgical treatment. Outcome measurements included the Short Form-36 (SF-36) bodily pain and physical function scores and the modified Oswestry Disability Index (ODI). At 3-month follow-up, individuals who chose discectomy had a significantly greater improvement in the outcome measurements. These differences somewhat narrowed at 2-year follow-up. The authors concluded that there was improvement with both surgical and nonsurgical treatment among individuals with persistent sciatica from LDH. However, those who chose surgical treatment reported greater improvements that those who elected nonsurgical treatment. The study is limited in its lack of randomization and relatively mid-term follow-up period.
In a prospective RCT, Peul et al. (2007) evaluated the safety and effectiveness of early discectomy when compared with nonsurgical conservative treatment in individuals who had persistent sciatica that did not resolve within 6 weeks. The primary outcome measurements were the Roland Disability Questionnaire, visual analog scale (VAS) pain score, and the individual's report of perceived recovery. Study participants were followed for 1 year. Of the 141 individuals assigned to undergo surgery, 89% (n=125) underwent discectomy after a mean of 2.2 weeks. Of the 142 individuals designated for conservative treatment, 39% (n=55) were treated surgically after a mean of 18.7 weeks. There was no statistically significant difference in disability scores during the first year (P=0.13). However, individuals assigned to the early discectomy group reported a faster rate of perceived recovery (P<0.001; hazard ratio, 1.97). The authors concluded that 1-year outcomes were similar for individuals assigned to early surgery and those assigned to conservative treatment. However, the rates of pain relief and perceived recovery were faster for those assigned to early discectomy. The study is limited in its short-term follow-up period.
In a systematic review, Chou et al. (2009) evaluated the available peer-reviewed literature to assess the safety and effectiveness of surgery for nonradicular back pain with common degenerative changes, radiculopathy with herniated lumbar disc, and symptomatic spinal stenosis. All relevant studies were methodologically assessed by two independent reviewers using criteria developed by Cochrane Back Review Group and Oxman. For individuals with radiculopathy with herniated lumbar disc, the authors found good evidence indicating that standard open discectomy and microdiscectomy were moderately superior to nonsurgical treatment for improvement in pain and function through 3 months.
In 2016, Gugliotta et al. published a prospective cohort study comparing open discectomy (n=297) with conservative treatment (n=73) for LDH. Assignment to treatment group was decided by physicians based on individuals’ clinical indications. Conservative treatment consisted of active physical therapy, education, and nonsteroidal anti-inflammatory drugs. Outcomes were the North American Spine Society (NASS) scores (back pain, neurogenic, function) and SF-36 scores (physical and mental function). Follow-up measurements were obtained at 6 weeks, 12 weeks, 1 year, and 2 years. Of the three different NASS scores measured at the four different follow-up times, the statistically significant differences in the surgery group over the conservative treatment group were in the NASS back pain score at 6 weeks and the NASS function score at 1 year. SF-36 physical and mental function scores were comparable between treatment groups at all follow-up points.
ANNULAR CLOSURE DEVICES
Barricaid Annular Closure Device
Kuršumović and Rath, in 2017, completed a retrospective analysis of 171 individuals who underwent limited lumbar discectomy with an ACD for LDH. Large annular defects were present in 154 individuals. Six symptomatic re-herniations were observed. Fifteen ACD mesh detachments from the titanium were noted. No symptomatic reherniations were observed in secondary herniation cases. The authors noted that there were study limitations, including retrospective design, lack of a comparative group, minimal exclusion criteria, small sample size, and short follow-up.
A retrospective analysis study was performed between March 2011 and December 2017. Martens et al. examined the safety and viability of an ACD limiting reherniation and reoperation in 60 individuals treated by a single surgeon undergoing minimally invasive lumbar discectomy with the assistance of an ACD. All the individuals had been diagnosed with a large defect and were treated via minimally invasive surgical techniques. The authors concluded that the use of an ACD during minimally invasive lumbar discectomy in a population of individuals with large herniations was associated with low rates of reherniation and reoperation at the index level; however, more research is required.
In 2018, Choy et al. performed a meta-analysis to determine a potential approach to reduce incidences of recurrent LDH and assess the current devices regarding their outcomes and complications. Three studies reported the use of Barricaid (ACD), whereas one study reported the use of Anulex (Xclose). A total of 24 symptomatic reherniations were reported among 811 discectomies with the ACD device compared to 51 of 645 in the control group. Per the authors, the conclusion of early results reached through this meta-analysis showed the use of Barricaid and Anulex devices are beneficial for short-term outcomes demonstrating reduction in symptomatic disc herniation with low postoperative complication rates. Long-term studies are required to further investigate the efficacy of such devices.
Thomé et al. (2018) published a multicenter RCT that evaluated whether the Barricaid ACD in adjunct to (LMD) would decrease reherniation and reoperation rates compared to LMD alone. Individuals with symptoms of LDH for at least 6 weeks with a large annular defect after microdiscectomy were included in the study. The individuals received a microdiscectomy with an additional bone-anchored ACD or only a LMD. The authors concluded that in individuals at high risk of herniation recurrence after LMD, annular closure with a bone-anchored implant lowers the risk of a symptomatic recurrence and reoperation; however, additional study to determine outcomes beyond 2 years with a bone-anchored ACD is warranted.
An assessment of annulus fibrosus repair after lumbar discectomy by the Ludwig Boltzmann Institute for Health Technology Assessment (Semlitsch and Geiger-Gritsch, 2019) found that the closure of annular defects after discectomy using the Barricaid device could be a meaningful intervention for a selected group of patients with a large annular defect to prevent reherniations and reoperations. However, a significant number of patients experienced problems with device integrity over a period of 2 years. In addition, these results are based on a few studies with a high risk of bias and published long-term results beyond a period of 2 years are missing. Similar results in terms of clinical effectiveness and safety were obtained for the Xclose system. However, only results from a single RCT with a high risk of bias are available.
In a randomized, multicenter trial, Nanda et al. (2019) examined whether implanting an ACD following lumbar discectomy in patients with large defects in the annulus fibrosus lowers the risk of reoperation after 4 years. Patients with large annular defects following single-level lumbar discectomy were intraoperatively randomly assigned to additionally receive an ACD or no treatment (controls). Clinical and imaging follow-up were performed at routine intervals over 4 years of follow-up. Main outcomes included reoperations at the treated lumbar level, leg pain scores on a VAS, ODI, Physical Component Summary (PCS), and Mental Component Summary (MCS) scores from the SF-36 questionnaire. Among 550 patients (ACD 272, control 278), the risk of reoperation over 4 years was 14.4% with ACD and 21.1% with controls (P=0.03). The reduction in reoperation risk with ACD was not significantly influenced by patient age (P=0.51), sex (P=0.34), body mass index (BMI; P=0.21), smoking status (P=0.85), level of herniation (P=0.26), leg pain severity at baseline (P=0.90), or ODI at baseline (P=0.54). All patient-reported outcomes improved in each group from baseline to 4 years (all P<0.001). The percentage of patients who achieved the minimal clinically important difference without a reoperation was proportionally higher in the ACD group compared with controls for leg pain (P=0.07), ODI (P=0.10), PCS (P=0.02), and MCS (P=0.06). The authors concluded that the addition of a bone-anchored ACD following lumbar discectomy in patients with large postsurgical annular defects reduced the risk of reoperation and provided better long-term pain and disability relief over 4 years compared with lumbar discectomy only.
The authors stated that this study had several drawbacks. First, the results presented were applicable only to patients with large postdiscectomy annular defects, who accounted for approximately 30% of all lumbar discectomy cases. Implantation of an ACD in patients with small annular defects cannot be justified clinically given the inherently low risk of symptom recurrence in these individuals. Additional patient characteristics that were crucial to achieving positive results included adequate disc height and nonosteoporotic bone mineral density (BMD) of the lumbar spine. Second, the decision to reoperate involved shared decision-making between the patient and surgeon and, thus, there was potential for bias in the reported reoperation rates. Finally, 5-year follow-up in this study is ongoing and these long-term outcomes are anxiously awaited to provide final comparative efficacy, safety, and cost-utility results of bone-anchored ACD implantation.
Kienzler et al. (2019), in a randomized, multicenter study, examined the 3-year results of lumbar discectomy with a bone-anchored ACD or lumbar discectomy only (controls) in patients at high risk for reherniation. The trial included patients with sciatica due to lumbar intervertebral disc herniation in whom conservative treatment failed. Patients with large annular defects after lumbar limited microdiscectomy were intraoperatively randomly assigned to receive ACD or control. Clinical and imaging follow-up was performed at routine intervals over 3 years. Main outcomes included rate of re-herniations, reoperations, and endplate changes; leg and back pain scores on a VAS; ODI; PCS; MCS scores from the SF-36; and adverse events (AEs) adjudicated by a data safety monitoring board. Among 554 randomly assigned patients, the modified intent-to-treat (ITT) population consisted of 272 patients in which ACD implantation was attempted and 278 receiving control; device implantation was not attempted in four patients assigned to ACD. Outcomes at 3 years favored ACD for symptomatic reherniation (14.8% vs 29.5%; P<0.001), reoperation (11.0% vs 19.3%; P=0.007), leg pain (21 vs 30; P<0.01), back pain (23 vs 30; P=0.01), ODI (18 vs 23; P=0.02), PCS (47 vs 44; P< 0.01), and MCS (52 vs 49; P<0.01). The frequency of all-cause serious AEs was comparable between groups (42.3% vs 44.5%; P=0.61). The authors stated that this study had several limitations. First, these findings were not applicable to all patients undergoing lumbar discectomy, but only the approximately 30% of cases at high risk of reherniation due to a large postsurgical annular defect. The ACD is not intended to be used in patients with smaller defects because treatment with a permanent implant is difficult to justify in this population owing to the relatively low risk of reherniation. Second, lack of patient and outcome-assessor blinding to treatment allocation may have biased patient-reported outcomes or the decision to reoperate. Third, although CT imaging with core laboratory reading is a strength of this trial, it may also be perceived as a limitation because the application of CT findings to routine clinical practice is unclear. Finally, longer follow-up is needed in this younger patient population to determine the durability of effect with ACD and to ensure there are no concerning late-onset safety or device-related complications. Although there was no association of vertebral endplate changes (VEPC) with clinical complications over 3 years among patients who received ACD, this should be confirmed in long-term follow-up.
In 2021, Thomé et al. examined whether a bone-anchored ACD in addition to LMD would result in lower reherniation and reoperation rates versus LMD alone. This trial reported the 5-year follow-up for enrolled patients between December 2010 and October 2014 at 21 clinical sites. Patients in this study had a large annular defect (6- to 10-mm width) following LMD for treatment of LDH. Statistical analysis was performed from November to December 2020. Subjects were treated with LMD with additional bone-anchored ACD (device group) or LMD only (control group). Main outcomes and measures included the incidence of symptomatic reherniation, reoperation, and AEs as well as changes in leg pain, ODI, and health-related quality of life QOL (HR-QOL) when comparing the device and control groups over 5 years of follow-up. Among 554 randomized subjects (mean [SD] age: 43 [11] years; 327 [59%] were men), 550 were included in the modified ITT efficacy population (device group: n=272; 270 [99%] were White); control group: n = 278; 273 [98%] were White) and 550 were included in the as-treated safety population (device group: n=267; control group: n=283). The risk of symptomatic reherniation (18.8% [SE, 2.5%] vs 31.6% [SE, 2.9%]; P<0.001) and reoperation (16.0% [SE, 2.3%] versus 22.6% [SE, 2.6%]; P=0.03) was lower in the device group. There were 53 reoperations in 40 patients in the device group and 82 reoperations in 58 patients in the control group. Scores for leg pain severity, ODI, and HR-QOL significantly improved over 5 years of follow-up with no clinically relevant differences between groups. The frequency of serious AEs was comparable between the treatment groups. Serious AEs associated with the device or procedure were less frequent in the device group (12.0% vs 20.5%; difference, -8.5%; 95 % CI: -14.6% to -2.3%; P=0.008).
The authors stated that this study had several limitations. First, the results were generalizable only to patients with large defects in the annulus fibrosus following lumbar discectomy. Second, most patients and all investigators were aware of treatment assignment; thus, it was possible that reoperation rates may have been influenced by performance bias. Third, patients in the trial were treated with limited lumbar discectomy with little to no removal of disc material within the intervertebral space. It was possible that lower reherniation rates could be achieved with aggressive disc resection, although intervertebral instability and spondylosis progression were potential risks with this surgical technique. Fourth, although end-plate changes in the device group were associated with a benign clinical course through 5 years of follow-up, their natural history over longer term follow-up is currently unclear. Finally, although the 5-year follow-up visit rate of 73% was typical of long-term clinical trials of spinal devices, the potential for bias owing to missing data must be acknowledged.
Kienzler et. al. (2021), in a noncomparative, single-center study, analyzed the incidence of endplate changes (EPC) and outcome after LMD with additional implantation of an ACD to prevent reherniation. This analysis included data from an RCT study arm of patients undergoing LMD with ACD implantation as well as additional patients undergoing ACD implantation at the authors' institution. Clinical findings (VAS, ODI), radiological outcome (reherniation, implant integrity, volume of EPC) and risk factors for EPC were assessed. A total of 72 patients (37 men, age of 47 ± 11.63 years) underwent LMD and ACD implantation between 2013 and 2016. A total of 71 (99%) patients presented with some degree of EPC during the follow-up period (14.67 ± 4.77 months). In the multivariate regression analysis, localization of the anchor was the only significant predictor of EPC (P=0.038). The largest EPC measured 4.2 cm3. Reherniation was documented in 17 (24%) patients (symptomatic: n=10; asymptomatic: n=7); 6 (8.3 %) patients with symptomatic reherniation underwent rediscectomy. Implant failure was documented in 19 (26.4%) patients, including anchor head breakage (n=1, 1.3%), dislocation of the whole device (n=5, 6.9%), and mesh dislocation into the spinal canal (n=13, 18%). Mesh subsidence within the EPC was documented in 15 (20.8%) patients; 7 (9.7%) patients underwent explantation of the entire or parts of the device. The authors concluded the ACD might prevent disc reherniation despite implant failure rates. Mechanical friction of the polymer mesh with the endplate was most likely the cause of EPC after ACD. Long-term clinical and radiological assessments are needed to examine the consequences of these findings. Limitations of this study was that it was a noncomparative, single-center study with a small patient cohort.
A meta-analysis of randomized and nonrandomized controlled trials was conducted by Wang et al. (2024) reviewing the clinical efficacy and safety of annular repair techniques on 2161 individuals. The pooled data analysis showed that adding the annular repair technique reduced postoperative recurrence rate, reoperation rate, and loss of intervertebral height compared with lumbar discectomy alone. Subgroup analysis based on different annular repair techniques showed that the Barricaid Annular Closure Device (ACD) was effective in preventing re-protrusion and reducing reoperation rates, while there was no significant difference between the other subgroups. The annulus fibrosus suture (AFS) did not improve the postoperative ODI. The authors concluded a lumbar discectomy combined with ACD can effectively reduce postoperative recurrence and reoperation rates in patients with LDH. AFS alone was less effective in reducing recurrence and reoperation rates and did not improve postoperative pain and function.
Xclose Tissue Repair System
An annular (annulus) repair/closure may be performed following a spinal decompression (discectomy) surgery. It has been proposed that annular closure may reduce the risk of disc reherniation and the need for a fusion. Examples of devices used in an annular repair include the Inclose Surgical Mesh System and Xclose Tissue Repair System.
The Xclose Tissue Repair System (Anulex Technologies, Inc., Minnetonka, MN) has received 510(k) clearance for use in soft tissue approximation for procedures such as general and orthopedic surgery. It is being investigated as a method of soft tissue reapproximation of the anulus fibrosus after a lumbar discectomy procedure. However, there is insufficient evidence of the clinical effectiveness of the Xclose Tissue Repair System following a lumbar discectomy procedure. RCTs are needed to determine whether closing the anulus following a lumbar discectomy procedure will result in improved clinical outcomes (i.e., decrease in reherniation rates). To evaluate the benefits of anulus fibrosis repair utilizing the Xclose Tissue Repair system, Anulex is sponsoring a prospective, controlled, randomized study that will compare discectomy patients who receive anular repair using the Xclose Tissue Repair System to those who receive a standard discectomy without using the Xclose. However, results from this study have not yet been published in the peer-reviewed medical literature.
Disc Annular Repair Technology (DART) System
The DART System (Magellan Spine Technologies, Inc., Irvine, CA) is a polyetheretherketone (PEEK) implant that provides closure of the annulus following a standard LMD procedure. When implanted, the DART is placed near the central axis of rotation along the posterior edge of the vertebral body. The device is aligned with the vertebral body load column, the strongest of the three primary spinal vertical load columns and is secured in place at the apophyseal ring, the densest bone of the vertebral body. There are no studies currently published in the peer-reviewed medical literature to support the efficacy and safety of the DART system, or that it will improve health outcomes for use in individuals for any indication. In April 2009, the DART System received CE Mark approval for marketing in Europe. To date, the DART System has not received FDA 510(k) clearance for marketing in the United States.
Inclose Surgical Mesh System
The Inclose Surgical Mesh System (Anulex Technologies, Inc., Minnetonka, MN) received FDA 510(k) clearance on August 18, 2005, and is proposed as an alternative procedure for annular repair following discectomy to reapproximate the compromised tissue of the annulus fibrosus. The device is composed of a mesh implant and two suture assemblies referred to as anchor bands. The surgical mesh implant is composed of polyethylene terephthalate (PET) monofilament expandable braided material that is preloaded on a disposable delivery tool inserted through the aperture of the tissue defect and affixed to surrounding soft tissue with the anchor bands. To date, no evidence was found in the peer-reviewed medical literature evaluating the efficacy and safety of the Inclose Surgical Mesh System for any indication.
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 RCTs, nonrandomized comparative studies, 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 RCT evidence is limited by a lack of high-quality trials. In most, 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 of the evidence, the RCTs have 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 two 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 two 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.
Among
other evidentiary
requirements, long-term, high-quality studies are needed to establish the safety and efficacy of ACD.
