uu.seUppsala University Publications
Change search
ReferencesLink to record
Permanent link

Direct link
A Randomized, Controlled Trial of Fusion Surgery for Lumbar Spinal Stenosis
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Orthopaedics. Karolinska Inst, Stockholm Spine Ctr, S-10401 Stockholm, Sweden..
Karolinska Inst, Dept Learning Informat Management & Eth, S-10401 Stockholm, Sweden.;Quantify Res, Stockholm, Sweden..
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Orthopaedics.
Karolinska Inst, Stockholm Spine Ctr, S-10401 Stockholm, Sweden..
Show others and affiliations
2016 (English)In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 374, no 15, 1413-1423 p.Article in journal (Refereed) PublishedText
Abstract [en]

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.

Place, publisher, year, edition, pages
2016. Vol. 374, no 15, 1413-1423 p.
National Category
Orthopedics
Identifiers
URN: urn:nbn:se:uu:diva-294662DOI: 10.1056/NEJMoa1513721ISI: 000374128400005PubMedID: 27074066OAI: oai:DiVA.org:uu-294662DiVA: diva2:932453
Funder
Swedish Association of Local Authorities and RegionsMedtronic, Sweden
Available from: 2016-06-01 Created: 2016-05-26 Last updated: 2016-06-01Bibliographically approved

Open Access in DiVA

No full text

Other links

Publisher's full textPubMed

Search in DiVA

By author/editor
Försth, PeterÖhagen, PatrikMichaelsson, KarlSanden, Bengt
By organisation
OrthopaedicsUCR-Uppsala Clinical Research Center
In the same journal
New England Journal of Medicine
Orthopedics

Search outside of DiVA

GoogleGoogle Scholar
The number of downloads is the sum of all downloads of full texts. It may include eg previous versions that are now no longer available

Altmetric score

Total: 22 hits
ReferencesLink to record
Permanent link

Direct link