The 2-Level Experience of Interlaminar Stabilization: 5-Year Follow-Up of a Prospective, Randomized Clinical Experience Compared to Fusion for the Sustainable Management of Spinal Stenosis

Abstract

Background: To alleviate the symptoms of lumbar spinal stenosis, widely accepted methods of surgical treatment include decompression alone and decompression with fusion. As an alternative to these methods, interlaminar stabilization (ILS) devices with decompression were introduced. There is a large amount of research dedicated to examining the efficacy of ILS devices in single-level procedures, but fewer studies focus on their efficacy in 2-level procedures. The purpose of this study was to compare decompression with instrumented posterolateral fusion to decompression with interlaminar stabilization in patients who require surgical treatment at 2 levels for lumbar spinal stenosis at 5 years postoperation. Methods: Of the 322 patients enrolled in the Investigational Device Exemption clinical trial, 116 required surgical treatment at 2 levels. The ILS group consisted of 77 patients, and the fusion group consisted of 39 patients. Efficacy was measured using composite clinical success (CCS). Patients achieve CCS if they achieve all 4 of the following outcomes: 15-point improvement from baseline Oswestry Disability Index (ODI); no reoperation or epidural injections; no persistent, new, or increasing neurological deficits; and no major device-related complications. Results: There was a 91% rate of follow-up within the participant population in the 5-year data. There was a difference trending toward significance between groups for the absence of reoperation or epidural injection, with 68.8% of ILS patients and only 51.3% of fusion patients meeting this criteria (P ¼ .065); 13.0% of ILS patients and 25.7% of fusion patients required secondary surgery. The percentage of patients achieving overall CCS was much greater in the ILS group than the fusion group, with 55.1% (38/69) of ILS patients and only 36.4% (12/33) of fusion patients achieving CCS at month 60 (P ¼ .077). With regard to the ODI, the visual analog scale back and worse leg pain, the Short Form-12, and the Zurich Claudication Questionnaire, both groups had significantly better results at every followup time point when compared to their respective baseline scores. Conclusions: The 2-level ILS patient group performed as well as, if not better than, the 2-level fusion group across almost all outcome measures, demonstrating both clinical outcome success and favorably low reoperation rates in patients who received ILS surgery. Clinical Relevance: This is the first 5-year analysis of the 2-level ILS experience, which supplements previous studies that describe the advantages of ILS by extending such advantages to 2-level cases. New Technology

More Than 1 in 3 Patients With Chronic Low Back Pain Continue to Use Opioids Long-term After Spinal Fusion

“…com/CJP/A846), while 32 (9.7%) reported that they tracked opioid use. However, of these 32, only 21 studies (6.4% of all studies) 41,[43][44][45][46][47]49,52,53,[56][57][58][60][61][62][63]65,[69][70][71][72] specifically reported opioid use out to at least 6 months (Table 2). Eleven of the 329 studies 42,48,50,51,54,55,59,64,[66][67][68] tracked opioid use before surgery or immediately after surgery but did not track opioids out at least 6 months.…”

“…Cohen's kappa for agreement among the independent reviewers for the title and abstract screen was moderate (k = 0.79) and for the full-text screen was almost perfect (k = 0.95). Detailed descriptions of the 21 studies 41,[43][44][45][46][47]49,52,53,[56][57][58][60][61][62][63]65,[69][70][71][72] that tracked longterm opioid use are provided in Table 2. There were 2286 pooled participants across all studies with a mean age ranging from 39.2 to 71.0 years, with 53.6% (n = 1226) female.…”

“…The number of participants in the fusion arm within each study ranged from 26 to 322. Of these studies, 12 were RCTs, 43,44,47,53,56,57,61,62,[69][70][71][72] 6 were prospective cohort studies, 45,46,52,58,60,63 and 3 were retrospective cohort studies. 41,49,65 The study follow-up period ranged from 7.2 to 72.0 months.…”

“…Sixteen 41,[44][45][46][47]52,53,[56][57][58]61,62,65,[70][71][72] of the 21 studies 41,43-47,49,52,53,56-58,60-63,65,69-72 (76%) were published between 2011 and 2020. For studies that tracked opioid use up to 6 months postsurgery, 57% (n = 12) were RCTs, 43,44,47,53,56,57,61,62,[69][70][71][72] 29% (n = 6) were prospective cohort studies 45,46,52,58,60,63 and 14% (n = 3) were retrospective cohort studies. 41,49,65 Studies that tracked opioid use <6 months or not at all were similar in study design parameters.…”

“…Similarities were found in compliance with reporting guidelines (STROBE or CONSORT checklists) between studies that reported opioids and those that did not (Appendix Table 2, Supplemental Digital Content 3, http://links.lww.com/ CJP/A847). Only 1 57 of the 12 RCTs 43,44,47,53,56,57,61,62,[69][70][71][72] tracking long-term opioids reported compliance with the CONSORT checklist, and none of the cohort studies reported using the STROBE checklist.…”