Peter Försth1, Gylfi Ólafsson1, Thomas Carlsson1, Anders Frost1, Fredrik Borgström1, Peter Fritzell1, Patrik Öhagen1, Karl Michaëlsson1, Bengt Sandén1. 1. From the Department of Surgical Sciences, Division of Orthopedics (P. Försth, T.C., P. Fritzell, K.M., B.S.), and the Uppsala Clinical Research Center (P.Ö., K.M.), Uppsala University, Uppsala, Stockholm Spine Center (P. Försth, A.F.), the Department of Learning, Informatics, Management, and Ethics, Karolinska Institutet (G.Ó., F.B.), and Quantify Research (G.Ó., F.B.), Stockholm, and Futurum-Academy for Health and Care, Neuro-orthopedic Center, Ryhov (P. Fritzell) - all in Sweden.
Abstract
BACKGROUND: The efficacy of fusion surgery in addition to decompression surgery in patients who have lumbar spinal stenosis, with or without degenerative spondylolisthesis, has not been substantiated in controlled trials. METHODS: We randomly assigned 247 patients between 50 and 80 years of age who had lumbar spinal stenosis at one or two adjacent vertebral levels to undergo eitherdecompression surgery plus fusion surgery (fusion group) or decompression surgery alone (decompression-alone group). Randomization was stratified according to the presence of preoperative degenerative spondylolisthesis (in 135 patients) or its absence. Outcomes were assessed with the use of patient-reported outcome measures, a 6-minute walk test, and a health economic evaluation. The primary outcome was the score on the Oswestry Disability Index (ODI; which ranges from 0 to 100, with higher scores indicating more severe disability) 2 years after surgery. The primary analysis, which was a per-protocol analysis, did not include the 14 patients who did not receive the assigned treatment and the 5 who were lost to follow-up. RESULTS: There was no significant difference between the groups in the mean score on the ODI at 2 years (27 in the fusion group and 24 in the decompression-alone group, P=0.24) or in the results of the 6-minute walk test (397 m in the fusion group and 405 m in the decompression-alone group, P=0.72). Results were similar between patients with and those without spondylolisthesis. Among the patients who had 5 years of follow-up and were eligible for inclusion in the 5-year analysis, there were no significant differences between the groups in clinical outcomes at 5 years. The mean length of hospitalization was 7.4 days in the fusion group and 4.1 days in the decompression-alone group (P<0.001). Operating time was longer, the amount of bleeding was greater, and surgical costs were higher in the fusion group than in the decompression-alone group. During a mean follow-up of 6.5 years, additional lumbar spine surgery was performed in 22% of the patients in the fusion group and in 21% of those in the decompression-alone group. CONCLUSIONS: Among patients with lumbar spinal stenosis, with or without degenerative spondylolisthesis, decompression surgery plus fusion surgery did not result in better clinical outcomes at 2 years and 5 years than did decompression surgery alone. (Funded by an Uppsala institutional Avtal om Läkarutbildning och Forskning [Agreement concerning Cooperation on Medical Education and Research] and others; Swedish Spinal Stenosis Study ClinicalTrials.gov number, NCT01994512.).
RCT Entities:
BACKGROUND: The efficacy of fusion surgery in addition to decompression surgery in patients who have lumbar spinal stenosis, with or without degenerative spondylolisthesis, has not been substantiated in controlled trials. METHODS: We randomly assigned 247 patients between 50 and 80 years of age who had lumbar spinal stenosis at one or two adjacent vertebral levels to undergo either decompression surgery plus fusion surgery (fusion group) or decompression surgery alone (decompression-alone group). Randomization was stratified according to the presence of preoperative degenerative spondylolisthesis (in 135 patients) or its absence. Outcomes were assessed with the use of patient-reported outcome measures, a 6-minute walk test, and a health economic evaluation. The primary outcome was the score on the Oswestry Disability Index (ODI; which ranges from 0 to 100, with higher scores indicating more severe disability) 2 years after surgery. The primary analysis, which was a per-protocol analysis, did not include the 14 patients who did not receive the assigned treatment and the 5 who were lost to follow-up. RESULTS: There was no significant difference between the groups in the mean score on the ODI at 2 years (27 in the fusion group and 24 in the decompression-alone group, P=0.24) or in the results of the 6-minute walk test (397 m in the fusion group and 405 m in the decompression-alone group, P=0.72). Results were similar between patients with and those without spondylolisthesis. Among the patients who had 5 years of follow-up and were eligible for inclusion in the 5-year analysis, there were no significant differences between the groups in clinical outcomes at 5 years. The mean length of hospitalization was 7.4 days in the fusion group and 4.1 days in the decompression-alone group (P<0.001). Operating time was longer, the amount of bleeding was greater, and surgical costs were higher in the fusion group than in the decompression-alone group. During a mean follow-up of 6.5 years, additional lumbar spine surgery was performed in 22% of the patients in the fusion group and in 21% of those in the decompression-alone group. CONCLUSIONS: Among patients with lumbar spinal stenosis, with or without degenerative spondylolisthesis, decompression surgery plus fusion surgery did not result in better clinical outcomes at 2 years and 5 years than did decompression surgery alone. (Funded by an Uppsala institutional Avtal om Läkarutbildning och Forskning [Agreement concerning Cooperation on Medical Education and Research] and others; Swedish Spinal Stenosis Study ClinicalTrials.gov number, NCT01994512.).
Authors: Christian Barz; Markus Melloh; Lukas P Staub; Sarah J Lord; Harry R Merk; Thomas Barz Journal: Eur Spine J Date: 2017-02-04 Impact factor: 3.134
Authors: Rene Balza; Sarah F Mercaldo; Connie Y Chang; Ambrose J Huang; Jad S Husseini; Arvin B Kheterpal; F Joseph Simeone; William E Palmer Journal: Skeletal Radiol Date: 2021-05-27 Impact factor: 2.199