Michael J Musacchio1, Carl Lauryssen2, Reginald J Davis3, Hyun W Bae4, John H Peloza5, Richard D Guyer6, Jack E Zigler6, Donna D Ohnmeiss7, Scott Leary8. 1. Department of Neurosurgery, NorthShore University HealthSystem, Evanston, IL. 2. NeuroTexas, Austin, TX. 3. Laser Spine Institute, Philadelphia, PA. 4. The Spine Institute, Santa Monica, CA. 5. Texas Back Institute, Frisco, TX. 6. Texas Back Institute, Plano, TX. 7. Texas Back Institute Research Foundation, Plano, TX. 8. Senta Clinic, San Diego, CA.
Abstract
INTRODUCTION: If nonoperative treatment for lumbar stenosis fails, surgery may be considered. This traditionally includes decompression often combined with fusion. Desire for less extensive surgery led to developing new techniques and implants, including an interlaminar device designed with the goal of providing segmental stability without fusion, following decompression. The purpose of this study was to investigate 5-year outcomes associated with an interlaminar device. METHODS: This prospective, randomized, controlled trial was conducted at 21 centers. Patients with moderate to severe lumbar stenosis at one or two contiguous levels and up to Grade I spondylolisthesis were randomized (2:1 ratio) to decompression and interlaminar stabilization (D+ILS; n=215) using the coflex(®) Interlaminar Stabilization(®) device (Paradigm Spine, LLC) or decompression and fusion with pedicle screws (D+PS; n=107). Clinical evaluations were made preoperatively and at 6 weeks and 3, 6, 12, 18, 24, 36, 48, and 60 months postoperatively. Overall Food and Drug Administration success criteria required that a patient meet 4 criteria: 1) >15 point improvement in Oswestry Disability Index (ODI) score; 2) no reoperation, revision, removal, or supplemental fixation; 3) no major device-related complication; and 4) no epidural steroid injection after surgery. RESULTS: At 5 years, 50.3% of D+ILS vs. 44% of D+PS patients (p>0.35) met the composite success criteria. Reoperation/revision rates were similar in the two groups (16.3% vs. 17.8%; p >0.90). Both groups had statistically significant improvement through 60 months in ODI scores with 80.6% of D+ILS patients and 73.2% of D+PS patients demonstrating >15 point improvement (p>0.30). VAS, SF-12, and ZCQ scores followed a similar pattern of maintained significant improvement throughout follow-up. On the SF-12 and ZCQ, D+ILS group scores were statistically significantly better during early follow-up compared to D+PS. In the D+ILS group, foraminal height, disc space height, and range of motion at the index level were maintained through 5 years. CONCLUSION: Both treatment groups achieved and maintained statistically significant improvements on multiple outcome assessments throughout 5-year follow-up. On some clinical measures, there were statistically significant differences during early follow-up favoring D+ILS. At no point were there significant differences favoring D+PS. Results of this 5-year follow-up study demonstrate that decompression and interlaminar stabilization with coflex is a viable alternative to traditional decompression and fusion in the treatment of patients with moderate to severe stenosis at one or two lumbar levels. LEVEL OF EVIDENCE AND ETHICAL STATEMENTS: This is a Level I study. Institutional approval was received at each of the sites participating in the trial. Each patient gave informed consent to participate in the trial.
RCT Entities:
INTRODUCTION: If nonoperative treatment for lumbar stenosis fails, surgery may be considered. This traditionally includes decompression often combined with fusion. Desire for less extensive surgery led to developing new techniques and implants, including an interlaminar device designed with the goal of providing segmental stability without fusion, following decompression. The purpose of this study was to investigate 5-year outcomes associated with an interlaminar device. METHODS: This prospective, randomized, controlled trial was conducted at 21 centers. Patients with moderate to severe lumbar stenosis at one or two contiguous levels and up to Grade I spondylolisthesis were randomized (2:1 ratio) to decompression and interlaminar stabilization (D+ILS; n=215) using the coflex(®) Interlaminar Stabilization(®) device (Paradigm Spine, LLC) or decompression and fusion with pedicle screws (D+PS; n=107). Clinical evaluations were made preoperatively and at 6 weeks and 3, 6, 12, 18, 24, 36, 48, and 60 months postoperatively. Overall Food and Drug Administration success criteria required that a patient meet 4 criteria: 1) >15 point improvement in Oswestry Disability Index (ODI) score; 2) no reoperation, revision, removal, or supplemental fixation; 3) no major device-related complication; and 4) no epidural steroid injection after surgery. RESULTS: At 5 years, 50.3% of D+ILS vs. 44% of D+PSpatients (p>0.35) met the composite success criteria. Reoperation/revision rates were similar in the two groups (16.3% vs. 17.8%; p >0.90). Both groups had statistically significant improvement through 60 months in ODI scores with 80.6% of D+ILS patients and 73.2% of D+PSpatients demonstrating >15 point improvement (p>0.30). VAS, SF-12, and ZCQ scores followed a similar pattern of maintained significant improvement throughout follow-up. On the SF-12 and ZCQ, D+ILS group scores were statistically significantly better during early follow-up compared to D+PS. In the D+ILS group, foraminal height, disc space height, and range of motion at the index level were maintained through 5 years. CONCLUSION: Both treatment groups achieved and maintained statistically significant improvements on multiple outcome assessments throughout 5-year follow-up. On some clinical measures, there were statistically significant differences during early follow-up favoring D+ILS. At no point were there significant differences favoring D+PS. Results of this 5-year follow-up study demonstrate that decompression and interlaminar stabilization with coflex is a viable alternative to traditional decompression and fusion in the treatment of patients with moderate to severe stenosis at one or two lumbar levels. LEVEL OF EVIDENCE AND ETHICAL STATEMENTS: This is a Level I study. Institutional approval was received at each of the sites participating in the trial. Each patient gave informed consent to participate in the trial.
Authors: James N Weinstein; Tor D Tosteson; Jon D Lurie; Anna N A Tosteson; Emily Blood; Brett Hanscom; Harry Herkowitz; Frank Cammisa; Todd Albert; Scott D Boden; Alan Hilibrand; Harley Goldberg; Sigurd Berven; Howard An Journal: N Engl J Med Date: 2008-02-21 Impact factor: 91.245
Authors: James F Zucherman; Ken Y Hsu; Charles A Hartjen; Thomas F Mehalic; Dante A Implicito; Michael J Martin; Donald R Johnson; Grant A Skidmore; Paul P Vessa; James W Dwyer; Stephen T Puccio; Joseph C Cauthen; Richard M Ozuna Journal: Spine (Phila Pa 1976) Date: 2005-06-15 Impact factor: 3.468
Authors: Frank S Kleinstück; Dieter Grob; Friederike Lattig; Viktor Bartanusz; Francois Porchet; Dezsö Jeszenszky; David O'Riordan; Anne F Mannion Journal: Spine (Phila Pa 1976) Date: 2009-05-15 Impact factor: 3.468
Authors: Björn H Strömqvist; Svante Berg; Paul Gerdhem; Ragnar Johnsson; Anders Möller; Tage Sahlstrand; Ahmed Soliman; Tycho Tullberg Journal: Spine (Phila Pa 1976) Date: 2013-08-01 Impact factor: 3.468
Authors: Steven M Falowski; Vipul Mangal; Jason Pope; Anish Patel; Mark Coleman; Dan Kendall; Richard Brouillette; Michael A Fishman Journal: J Pain Res Date: 2021-05-31 Impact factor: 3.133
Authors: Celeste Abjornson; Byung-Jo Victor Yoon; Tucker Callanan; Daniel Shein; Samuel Grinberg; Frank P Cammisa Journal: Int J Spine Surg Date: 2018-03-30