Lumbar Facet Arthroplasty Versus Fusion for Grade-I Degenerative Spondylolisthesis with Stenosis: A Prospective Randomized Controlled Trial.
Journal
The Journal of bone and joint surgery. American volume
ISSN: 1535-1386
Titre abrégé: J Bone Joint Surg Am
Pays: United States
ID NLM: 0014030
Informations de publication
Date de publication:
07 May 2024
07 May 2024
Historique:
medline:
7
5
2024
pubmed:
7
5
2024
entrez:
7
5
2024
Statut:
aheadofprint
Résumé
The comparative effectiveness of decompression plus lumbar facet arthroplasty versus decompression plus instrumented lumbar spinal fusion in patients with lumbar spinal stenosis and grade-I degenerative spondylolisthesis is unknown. In this randomized, controlled, Food and Drug Administration Investigational Device Exemption trial, we assigned patients who had single-level lumbar spinal stenosis and grade-I degenerative spondylolisthesis to undergo decompression plus lumbar facet arthroplasty (arthroplasty group) or decompression plus fusion (fusion group). The primary outcome was a predetermined composite clinical success score. Secondary outcomes included the Oswestry Disability Index (ODI), visual analog scale (VAS) back and leg pain, Zurich Claudication Questionnaire (ZCQ), Short Form (SF)-12, radiographic parameters, surgical variables, and complications. A total of 321 adult patients were randomized in a 2:1 fashion, with 219 patients assigned to undergo facet arthroplasty and 102 patients assigned to undergo fusion. Of these, 113 patients (51.6%) in the arthroplasty group and 47 (46.1%) in the fusion group who had either reached 24 months of postoperative follow-up or were deemed early clinical failures were included in the primary outcome analysis. The arthroplasty group had a higher proportion of patients who achieved composite clinical success than did the fusion group (73.5% versus 25.5%; p < 0.001), equating to a between-group difference of 47.9% (95% confidence interval, 33.0% to 62.8%). The arthroplasty group outperformed the fusion group in most patient-reported outcome measures (including the ODI, VAS back pain, and all ZCQ component scores) at 24 months postoperatively. There were no significant differences between groups in surgical variables or complications, except that the fusion group had a higher rate of developing symptomatic adjacent segment degeneration. Among patients with lumbar spinal stenosis and grade-I degenerative spondylolisthesis, lumbar facet arthroplasty was associated with a higher rate of composite clinical success than fusion was at 24 months postoperatively. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
Sections du résumé
BACKGROUND
BACKGROUND
The comparative effectiveness of decompression plus lumbar facet arthroplasty versus decompression plus instrumented lumbar spinal fusion in patients with lumbar spinal stenosis and grade-I degenerative spondylolisthesis is unknown.
METHODS
METHODS
In this randomized, controlled, Food and Drug Administration Investigational Device Exemption trial, we assigned patients who had single-level lumbar spinal stenosis and grade-I degenerative spondylolisthesis to undergo decompression plus lumbar facet arthroplasty (arthroplasty group) or decompression plus fusion (fusion group). The primary outcome was a predetermined composite clinical success score. Secondary outcomes included the Oswestry Disability Index (ODI), visual analog scale (VAS) back and leg pain, Zurich Claudication Questionnaire (ZCQ), Short Form (SF)-12, radiographic parameters, surgical variables, and complications.
RESULTS
RESULTS
A total of 321 adult patients were randomized in a 2:1 fashion, with 219 patients assigned to undergo facet arthroplasty and 102 patients assigned to undergo fusion. Of these, 113 patients (51.6%) in the arthroplasty group and 47 (46.1%) in the fusion group who had either reached 24 months of postoperative follow-up or were deemed early clinical failures were included in the primary outcome analysis. The arthroplasty group had a higher proportion of patients who achieved composite clinical success than did the fusion group (73.5% versus 25.5%; p < 0.001), equating to a between-group difference of 47.9% (95% confidence interval, 33.0% to 62.8%). The arthroplasty group outperformed the fusion group in most patient-reported outcome measures (including the ODI, VAS back pain, and all ZCQ component scores) at 24 months postoperatively. There were no significant differences between groups in surgical variables or complications, except that the fusion group had a higher rate of developing symptomatic adjacent segment degeneration.
CONCLUSIONS
CONCLUSIONS
Among patients with lumbar spinal stenosis and grade-I degenerative spondylolisthesis, lumbar facet arthroplasty was associated with a higher rate of composite clinical success than fusion was at 24 months postoperatively.
LEVEL OF EVIDENCE
METHODS
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
Identifiants
pubmed: 38713762
doi: 10.2106/JBJS.23.00719
pii: 00004623-990000000-01088
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright © 2024 The Authors. Published by The Journal of Bone and Joint Surgery, Incorporated. All rights reserved.
Déclaration de conflit d'intérêts
Disclosure: This study was funded by Premia Spine (the manufacturer of the device being studied), which funded third-party data management and statistical analysis as well as the study coordinators at the study sites. The Article Processing Charge for open access publication was funded by Premia Spine. The Disclosure of Potential Conflicts of Interest forms are provided with the online version of the article (http://links.lww.com/JBJS/H984).
Références
Bae HW, Rajaee SS, Kanim LE. Nationwide trends in the surgical management of lumbar spinal stenosis. Spine (Phila Pa 1976). 2013 May 15;38(11):916-26.
Martin BI, Mirza SK, Spina N, Spiker WR, Lawrence B, Brodke DS. Trends in Lumbar Fusion Procedure Rates and Associated Hospital Costs for Degenerative Spinal Diseases in the United States, 2004 to 2015. Spine (Phila Pa 1976). 2019 Mar 1;44(5):369-76.
Fingar KR, Stocks C, Weiss AJ, Steiner CA. Most frequent operating room procedures performed in US Hospitals, 2003–2012. 2014 Dec. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb. Statistical Brief #186.
Weinstein JN, Lurie JD, Tosteson TD, Hanscom B, Tosteson AN, Blood EA, Birkmeyer NJ, Hilibrand AS, Herkowitz H, Cammisa FP, Albert TJ, Emery SE, Lenke LG, Abdu WA, Longley M, Errico TJ, Hu SS. Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. N Engl J Med. 2007 May 31;356(22):2257-70.
Försth P, Ólafsson G, Carlsson T, Frost A, Borgström F, Fritzell P, Öhagen P, Michaëlsson K, Sandén B. A Randomized, Controlled Trial of Fusion Surgery for Lumbar Spinal Stenosis. N Engl J Med. 2016 Apr 14;374(15):1413-23.
Ghogawala Z, Dziura J, Butler WE, Dai F, Terrin N, Magge SN, Coumans JV, Harrington JF, Amin-Hanjani S, Schwartz JS, Sonntag VK, Barker FG 2nd, Benzel EC. Laminectomy plus Fusion versus Laminectomy Alone for Lumbar Spondylolisthesis. N Engl J Med. 2016 Apr 14;374(15):1424-34.
Ulrich NH, Burgstaller JM, Valeri F, Pichierri G, Betz M, Fekete TF, Wertli MM, Porchet F, Steurer J, Farshad M; Lumbar Stenosis Outcome Study Group. Incidence of Revision Surgery After Decompression With vs Without Fusion Among Patients With Degenerative Lumbar Spinal Stenosis. JAMA Netw Open. 2022 Jul 1;5(7):e2223803.
Martin BI, Mirza SK, Comstock BA, Gray DT, Kreuter W, Deyo RA. Reoperation rates following lumbar spine surgery and the influence of spinal fusion procedures. Spine (Phila Pa 1976). 2007 Feb 1;32(3):382-7.
Ghiselli G, Wang JC, Bhatia NN, Hsu WK, Dawson EG. Adjacent segment degeneration in the lumbar spine. J Bone Joint Surg Am. 2004 Jul;86(7):1497-503.
Cummins D, Hindoyan K, Wu HH, Theologis AA, Callahan M, Tay B, Berven S. Reoperation and Mortality Rates Following Elective 1 to 2 Level Lumbar Fusion: A Large State Database Analysis. Global Spine J. 2022 Oct;12(8):1708-14.
Adogwa O, Owens R, Karikari I, Agarwal V, Gottfried ON, Bagley CA, Isaacs RE, Cheng JS. Revision lumbar surgery in elderly patients with symptomatic pseudarthrosis, adjacent-segment disease, or same-level recurrent stenosis. Part 2. A cost-effectiveness analysis: clinical article. J Neurosurg Spine. 2013 Feb;18(2):147-53.
Raman T, Nayar SK, Liu S, Skolasky RL, Kebaish KM. Cost-Effectiveness of Primary and Revision Surgery for Adult Spinal Deformity. Spine (Phila Pa 1976). 2018 Jun 1;43(11):791-7.
Coric D, Nassr A, Kim PK, Welch WC, Robbins S, DeLuca S, Whiting D, Chahlavi A, Pirris SM, Groff MW, Chi JH, Huang JH, Kent R, Whitmore RG, Meyer SA, Arnold PM, Patel AI, Orr RD, Krishnaney A, Boltes P, Anekstein Y, Steinmetz MP. Prospective, randomized controlled multicenter study of posterior lumbar facet arthroplasty for the treatment of spondylolisthesis. J Neurosurg Spine. 2022 Sep 23;38(1):115-25.
Haleem S, Ahmed A, Ganesan S, McGillion SF, Fowler JL. Mean 5-Year Follow-Up Results of a Facet Replacement Device in the Treatment of Lumbar Spinal Stenosis and Degenerative Spondylolisthesis. World Neurosurg. 2021 Aug;152:e645-51.
Pinter ZW, Freedman BA, Nassr A, Sebastian AS, Coric D, Welch WC, Steinmetz MP, Robbins SE, Ament J, Anand N, Arnold P, Baron E, Huang J, Whitmore R, Whiting D, Tahernia D, Sandhu F, Chahlavi A, Cheng J, Chi J, Pirris S, Groff M, Fabi A, Meyer S, Kushwaha V, Kent R, DeLuca S, Smorgick Y, Anekstein Y; TOPS Study Group. A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis: Results from the Total Posterior Spine System (TOPS) IDE Study. Clin Spine Surg. 2023 Mar 1;36(2):E59-69.
Smorgick Y, Mirovsky Y, Floman Y, Rand N, Millgram M, Anekstein Y. Long-term results for total lumbar facet joint replacement in the management of lumbar degenerative spondylolisthesis. J Neurosurg Spine. 2019 Oct 4:1-6.
Bae HW, Davis RJ, Lauryssen C, Leary S, Maislin G, Musacchio MJ Jr. Three-Year Follow-up of the Prospective, Randomized, Controlled Trial of Coflex Interlaminar Stabilization vs Instrumented Fusion in Patients With Lumbar Stenosis. Neurosurgery. 2016 Aug;79(2):169-81.
Zigler JE, Delamarter RB. Five-year results of the prospective, randomized, multicenter, Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential arthrodesis for the treatment of single-level degenerative disc disease. J Neurosurg Spine. 2012 Dec;17(6):493-501.
Carragee EJ, Cheng I. Minimum acceptable outcomes after lumbar spinal fusion. Spine J. 2010 Apr;10(4):313-20.
Koslosky E, Gendelberg D. Classification in Brief: The Meyerding Classification System of Spondylolisthesis. Clin Orthop Relat Res. 2020 May;478(5):1125-30.
Fukushima M, Oka H, Oshima Y, Yuzawa Y, Matsudaira K, Tanaka S, Inanami H. Evaluation of the Minimum Clinically Important Differences of the Zurich Claudication Questionnaire in Patients With Lumbar Spinal Stenosis. Clin Spine Surg. 2020 Dec;33(10):E499-503.
Kovacs FM, Abraira V, Royuela A, Corcoll J, Alegre L, Cano A, Muriel A, Zamora J, del Real MT, Gestoso M, Mufraggi N. Minimal clinically important change for pain intensity and disability in patients with nonspecific low back pain. Spine (Phila Pa 1976). 2007 Dec 1;32(25):2915-20.
Bhandari M, Tornetta P 3rd, Rampersad SA, Sprague S, Heels-Ansdell D, Sanders DW, Schemitsch EH, Swiontkowski M, Walter S; SPRINT Investigators. (Sample) size matters! An examination of sample size from the SPRINT trial study to prospectively evaluate reamed intramedullary nails in patients with tibial fractures. J Orthop Trauma. 2013 Apr;27(4):183-8.
Patchell RA, Tibbs PA, Regine WF, Payne R, Saris S, Kryscio RJ, Mohiuddin M, Young B. Direct decompressive surgical resection in the treatment of spinal cord compression caused by metastatic cancer: a randomised trial. Lancet. 2005 Aug 20-26;366(9486):643-8.
U.S. Food and Drug Administration. E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials Guidance for Industry. 2021 May. Accessed 2024 Mar 6. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e9r1-statistical-principles-clinical-trials-addendum-estimands-and-sensitivity-analysis-clinical
Pham MH, Mehta VA, Patel NN, Jakoi AM, Hsieh PC, Liu JC, Wang JC, Acosta FL. Complications associated with the Dynesys dynamic stabilization system: a comprehensive review of the literature. Neurosurg Focus. 2016 Jan;40(1):E2.
National Library of Medicine. A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis. 2020. Accessed 2024 Mar 6. https://clinicaltrials.gov/ct2/show/results/NCT00401518
Bokov A, Bulkin A, Aleynik A, Kutlaeva M, Mlyavykh S. Pedicle Screws Loosening in Patients With Degenerative Diseases of the Lumbar Spine: Potential Risk Factors and Relative Contribution. Global Spine J. 2019 Feb;9(1):55-61.
Galbusera F, Volkheimer D, Reitmaier S, Berger-Roscher N, Kienle A, Wilke HJ. Pedicle screw loosening: a clinically relevant complication? Eur Spine J. 2015 May;24(5):1005-16.
McAfee P, Khoo LT, Pimenta L, Capuccino A, Sengoz A, Coric D, Hes R, Conix B, Asgarzadie F, Hamzaoglu A, Mirofsky Y, Anekstein Y. Treatment of lumbar spinal stenosis with a total posterior arthroplasty prosthesis: implant description, surgical technique, and a prospective report on 29 patients. Neurosurg Focus. 2007 Jan 15;22(1):E13.