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@NEJM Ask the Authors & Experts: A Randomized Controlled Trial of Fusion Surgery for Lumbar Spinal Stenosis AND Decompression and Fusion versus Laminectomy for Lumbar Spondylolisthesis

Original Article


Decompression and Fusion versus Laminectomy for Lumbar Spondylolisthesis


Zoher Ghogawala, M.D.; James Dziura, Ph.D.; William E. Butler, M.D.; Feng Dai, Ph.D.; Norma Terrin, Ph.D.; Subu N. Magge, M.D.; Jean-Valery C.E. Coumans, M.D.; J. Fred Harrington, M.D.; Sepideh Amin-Hanjani, M.D.; Volker K.H. Sonntag, M.D.; Fred G. Barker II, M.D.; Edward C. Benzel, M.D.
N Engl J Med 2016; 374: | April 13, 2016 | DOI:10.1056/


BACKGROUND
The comparative effectiveness of adding instrumented lumbar spinal fusion to decompressive laminectomy for patients with symptomatic lumbar grade I degenerative spondylolisthesis with spinal stenosis is unknown. 


METHODS
A randomized controlled trial was conducted in patients aged 50-80 with stable degenerative spondylolisthesis (3-14 mm) and symptomatic lumbar spinal stenosis. Patients were randomized to receive laminectomy alone or laminectomy with posterolateral instrumented fusion. Primary outcome was change in Short Form-36 physical component summary (SF-36 PCS, range 0 to 100, higher scores=better quality of life) score 2 years post-operatively. Secondary outcome was Oswestry Disability Index (range 0 to 100, higher scores=more back pain disability). Patients were followed for 4 years. 


RESULTS
66 patients were randomized; Mean age was 67 years (80% female). Follow-up rate was 89% at 1 year, 86% at 2 years, and 68% at 4 years. Greater improvement (15.2) in SF-36 PCS scores was observed following fusion compared with laminectomy alone (9.5) at 2 years (difference of 5.7; 95% CI, 0.1 to 11.3; P=0.046). SF-36 PCS improvements with fusion remained superior at 3 (P=0.02) and 4 years (P=0.02). Improvements in back pain related disability were not significantly different (-17.9 laminectomy vs. -26.3 fusion, P=0.06). Fusion was associated with more blood loss and longer hospital stays (P<0.001 for both). Cumulative re-operation rate was 13.9% for fusion vs. 33.5% for laminectomy alone (P=0.05).


CONCLUSIONS
Compared with laminectomy alone, lumbar spinal fusion added to laminectomy for degenerative grade I spondylolisthesis was associated with modest improvement in overall physical health related quality of life. (ClinicalTrials.gov number, NCT00109213)


 Originally Appeared in The New England Journal of Medicine on April 13, 2016.


Click here to read the original article.


Original Article


A Randomized Controlled Trial of Fusion Surgery for Lumbar Spinal Stenosis


Peter Försth, M.D. Ph.D.; Gylfi Ólafsson, M.Sc.; Thomas Carlsson, M.D.; Anders Frost, M.D., Ph.D.; Fredrik Borgström, Ph.D.; Peter Fritzell, M.D., Ph.D.; Patrik Öhagen; Karl Michaëlsson, M.D., Ph.D.; Bengt Sandén, M.D., Ph.D.



N Engl J Med April 13, 2016 | DOI:10.1056/


BACKGROUND
The efficacy of fusion surgery in addition to decompression 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 aged 50-80 years with lumbar spinal stenosis on one or two adjacent levels to undergo surgical decompression with fusion or decompression alone. Randomization was stratified by preoperative spondylolisthesis (n=135). Outcomes assessed were patient-reported measures, a 6-minute walking test and a health economic evaluation. The primary endpoint was the Oswestry Disability Index (ODI, range 0 to 100, higher scores indicate more disability) 2 years after surgery. The primary analysis excluded the fourteen patients who did not receive the allocated treatment and the five who were lost to follow-up.


RESULTS
There was no significant difference in Oswestry Disability Index at 2 years (mean 27 units in the fusion group and 24 units in the decompression group, P=0.24). There also were no significant differences in the 6-minute walking test (397 vs. 405 meters, P=0.72). Results were similar in patients with and without spondylolisthesis. Among the 153 patients enrolled early enough to have completed 5 years of follow-up, there were no differences between the groups in 5 year clinical outcomes. Length of hospitalization was 7.4 days after fusion and 4.1 days after decompression alone (P<0.001). Operation time, bleeding and surgical costs were higher in fusion patients. During a mean follow up of 6.5 years, additional lumbar spine surgery was done in 22% of the patients after fusion and in 21% after decompression. 


CONCLUSIONS
Lumbar fusion with decompression surgery did not improve clinical outcomes at 2 and 5 years compared with decompression surgery alone in patients with lumbar spinal stenosis, with or without degenerative spondylolisthesis. (ClinicalTrials.gov number, NCT01994512)


 Originally Appeared in The New England Journal of Medicine on April 13, 2016.


Click here to read the original article.