Zoher Ghogawala1, James Dziura1, William E Butler1, Feng Dai1, Norma Terrin1, Subu N Magge1, Jean-Valery C E Coumans1, J Fred Harrington1, Sepideh Amin-Hanjani1, J Sanford Schwartz1, Volker K H Sonntag1, Fred G Barker1, Edward C Benzel1. 1. From the Alan L. and Jacqueline B. Stuart Spine Research Center, the Department of Neurosurgery, Lahey Hospital and Medical Center, Burlington (Z.G., S.N.M.), and the Department of Neurosurgery, Massachusetts General Hospital (W.E.B., J.-V.C.E.C., F.G.B.), and Tufts Clinical and Translational Science Institute, Tufts University School of Medicine (N.T.), Boston - all in Massachusetts; Wallace Trials Center, Greenwich Hospital, Greenwich (Z.G.), and Yale Center for Analytical Sciences, Yale School of Public Health, New Haven (J.D., F.D.) - both in Connecticut; the Department of Neurosurgery, University of New Mexico, Albuquerque (J.F.H.); the Department of Neurosurgery, University of Illinois at Chicago, Chicago (S.A.-H.); Perelman School of Medicine (J.S.S.), Wharton School of Business (J.S.S), and the Leonard Davis Institute (J.S.S.), University of Pennsylvania, Philadelphia; Barrow Neurosurgical Associates, Barrow Neurological Institute, Phoenix, AZ (V.K.H.S.); and the Center for Spine Health and the Department of Neurosurgery, Cleveland Clinic Foundation, Cleveland (E.C.B.).
Abstract
BACKGROUND: The comparative effectiveness of performing instrumented (rigid pedicle screws affixed to titanium alloy rods) lumbar spinal fusion in addition to decompressive laminectomy in patients with symptomatic lumbar grade I degenerative spondylolisthesis with spinal stenosis is unknown. METHODS: In this randomized, controlled trial, we assigned patients, 50 to 80 years of age, who had stable degenerative spondylolisthesis (degree of spondylolisthesis, 3 to 14 mm) and symptomatic lumbar spinal stenosis to undergo eitherdecompressive laminectomy alone (decompression-alone group) or laminectomy with posterolateral instrumented fusion (fusion group). The primary outcome measure was the change in the physical-component summary score of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36; range, 0 to 100, with higher scores indicating better quality of life) 2 years after surgery. The secondary outcome measure was the score on the Oswestry Disability Index (range, 0 to 100, with higher scores indicating more disability related to back pain). Patients were followed for 4 years. RESULTS: A total of 66 patients (mean age, 67 years; 80% women) underwent randomization. The rate of follow-up was 89% at 1 year, 86% at 2 years, and 68% at 4 years. The fusion group had a greater increase in SF-36 physical-component summary scores at 2 years after surgery than did the decompression-alone group (15.2 vs. 9.5, for a difference of 5.7; 95% confidence interval, 0.1 to 11.3; P=0.046). The increases in the SF-36 physical-component summary scores in the fusion group remained greater than those in the decompression-alone group at 3 years and at 4 years (P=0.02 for both years). With respect to reductions in disability related to back pain, the changes in the Oswestry Disability Index scores at 2 years after surgery did not differ significantly between the study groups (-17.9 in the decompression-alone group and -26.3 in the fusion group, P=0.06). More blood loss and longer hospital stays occurred in the fusion group than in the decompression-alone group (P<0.001 for both comparisons). The cumulative rate of reoperation was 14% in the fusion group and 34% in the decompression-alone group (P=0.05). CONCLUSIONS: Among patients with degenerative grade I spondylolisthesis, the addition of lumbar spinal fusion to laminectomy was associated with slightly greater but clinically meaningful improvement in overall physical health-related quality of life than laminectomy alone. (Funded by the Jean and David Wallace Foundation and others; SLIP ClinicalTrials.gov number, NCT00109213.).
RCT Entities:
BACKGROUND: The comparative effectiveness of performing instrumented (rigid pedicle screws affixed to titanium alloy rods) lumbar spinal fusion in addition to decompressive laminectomy in patients with symptomatic lumbar grade I degenerative spondylolisthesis with spinal stenosis is unknown. METHODS: In this randomized, controlled trial, we assigned patients, 50 to 80 years of age, who had stable degenerative spondylolisthesis (degree of spondylolisthesis, 3 to 14 mm) and symptomatic lumbar spinal stenosis to undergo either decompressive laminectomy alone (decompression-alone group) or laminectomy with posterolateral instrumented fusion (fusion group). The primary outcome measure was the change in the physical-component summary score of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36; range, 0 to 100, with higher scores indicating better quality of life) 2 years after surgery. The secondary outcome measure was the score on the Oswestry Disability Index (range, 0 to 100, with higher scores indicating more disability related to back pain). Patients were followed for 4 years. RESULTS: A total of 66 patients (mean age, 67 years; 80% women) underwent randomization. The rate of follow-up was 89% at 1 year, 86% at 2 years, and 68% at 4 years. The fusion group had a greater increase in SF-36 physical-component summary scores at 2 years after surgery than did the decompression-alone group (15.2 vs. 9.5, for a difference of 5.7; 95% confidence interval, 0.1 to 11.3; P=0.046). The increases in the SF-36 physical-component summary scores in the fusion group remained greater than those in the decompression-alone group at 3 years and at 4 years (P=0.02 for both years). With respect to reductions in disability related to back pain, the changes in the Oswestry Disability Index scores at 2 years after surgery did not differ significantly between the study groups (-17.9 in the decompression-alone group and -26.3 in the fusion group, P=0.06). More blood loss and longer hospital stays occurred in the fusion group than in the decompression-alone group (P<0.001 for both comparisons). The cumulative rate of reoperation was 14% in the fusion group and 34% in the decompression-alone group (P=0.05). CONCLUSIONS: Among patients with degenerative grade I spondylolisthesis, the addition of lumbar spinal fusion to laminectomy was associated with slightly greater but clinically meaningful improvement in overall physical health-related quality of life than laminectomy alone. (Funded by the Jean and David Wallace Foundation and others; SLIP ClinicalTrials.gov number, NCT00109213.).
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: Zhao Lang; Jing-Sheng Li; Felix Yang; Yan Yu; Kamran Khan; Louis G Jenis; Thomas D Cha; James D Kang; Guoan Li Journal: Eur Spine J Date: 2018-06-28 Impact factor: 3.134
Authors: Andrew J Schoenfeld; Heeren Makanji; Wei Jiang; Tracey Koehlmoos; Christopher M Bono; Adil H Haider Journal: Clin Orthop Relat Res Date: 2017-12 Impact factor: 4.176