Minimally invasive decompression versus open laminectomy for central stenosis of the lumbar spine: pragmatic comparative effectiveness study

Ulf S Nerland; Asgeir S Jakola; Ole Solheim; Clemens Weber; Vidar Rao; Greger Lønne; Tore K Solberg; Øyvind Salvesen; Sven M Carlsen; Øystein P Nygaard; Sasha Gulati

doi:10.1136/bmj.h1603

Minimally invasive decompression versus open laminectomy for central stenosis of the lumbar spine: pragmatic comparative effectiveness study

BMJ. 2015 Apr 1:350:h1603. doi: 10.1136/bmj.h1603.

Authors

Affiliations

¹ Department of Neurosurgery, St Olavs University Hospital, Trondheim, Norway Department of Neuroscience, Norwegian University of Science and Technology, Trondheim, Norway.
² Department of Neurosurgery, St Olavs University Hospital, Trondheim, Norway Department of Neurosurgery, Sahlgrenska University Hospital, Gothenburg, Sweden National Advisory Unit in Ultrasound and Image-Guided Surgery, St Olavs University Hospital, Trondheim, Norway.
³ Department of Neurosurgery, St Olavs University Hospital, Trondheim, Norway Department of Neuroscience, Norwegian University of Science and Technology, Trondheim, Norway National Advisory Unit in Ultrasound and Image-Guided Surgery, St Olavs University Hospital, Trondheim, Norway.
⁴ Department of Neurosurgery, St Olavs University Hospital, Trondheim, Norway Department of Neuroscience, Norwegian University of Science and Technology, Trondheim, Norway National Advisory Unit on Spinal Surgery Center for Spinal Disorders, St Olavs University Hospital, Trondheim, Norway.
⁵ Department of Neuroscience, Norwegian University of Science and Technology, Trondheim, Norway Department of Orthopedics, Innlandet Hospital Trust, Brumunddal, Norway.
⁶ Department of Neurosurgery, University Hospital of Northern Norway, Tromsø, Norway The Norwegian National Registry for Spine Surgery, University Hospital of Northern Norway), Tromsø, Norway.
⁷ Unit for Applied Clinical Research, Norwegian University of Science and Technology, Trondheim, Norway.
⁸ Unit for Applied Clinical Research, Norwegian University of Science and Technology, Trondheim, Norway Department of Endocrinology, St Olavs University Hospital, Trondheim, Norway.
⁹ Department of Neurosurgery, St Olavs University Hospital, Trondheim, Norway Department of Neuroscience, Norwegian University of Science and Technology, Trondheim, Norway National Advisory Unit on Spinal Surgery Center for Spinal Disorders, St Olavs University Hospital, Trondheim, Norway Norwegian Centre of Competence in Deep Brain Stimulation for Movement Disorders, St Olavs University Hospital, Trondheim, Norway sashagulati@hotmail.com.

Abstract

Objective: To test the equivalence for clinical effectiveness between microdecompression and laminectomy in patients with central lumbar spinal stenosis.

Design: Multicentre observational study.

Setting: Prospective data from the Norwegian Registry for Spine Surgery.

Participants: 885 patients with central stenosis of the lumbar spine who underwent surgery at 34 Norwegian orthopaedic or neurosurgical departments. Patients were treated from October 2006 to December 2011.

Interventions: Laminectomy and microdecompression.

Main outcome measures: The primary outcome was change in Oswestry disability index score one year after surgery. Secondary endpoints were quality of life (EuroQol EQ-5D), perioperative complications, and duration of surgical procedures and hospital stays. A blinded biostatistician performed predefined statistical analyses in unmatched and propensity matched cohorts.

Results: The study was powered to detect a difference between the groups of eight points on the Oswestry disability index at one year. 721 patients (81%) completed the one year follow-up. Equivalence between microdecompression and laminectomy was shown for the Oswestry disability index (difference 1.3 points, 95% confidence interval -1.36 to 3.92, P<0.001 for equivalence). Equivalence was confirmed in the propensity matched cohort and full information regression analyses. No difference was found between groups in quality of life (EQ-5D) one year after surgery. The number of patients with complications was higher in the laminectomy group (15.0% v 9.8%, P=0.018), but after propensity matching for complications the groups did not differ (P=0.23). The duration of surgery for single level decompression was shorter in the microdecompression group (difference 11.2 minutes, 95% confidence interval 4.9 to 17.5, P<0.001), but after propensity matching the groups did not differ (P=0.15). Patients in the microdecompression group had shorter hospital stays, both for single level decompression (difference 1.5 days, 95% confidence interval 1.7 to 2.6, P<0.001) and two level decompression (0.8 days, 1.0 to 2.2, P=0.003).

Conclusion: At one year the effectiveness of microdecompression is equivalent to laminectomy in the surgical treatment of central stenosis of the lumbar spine. Favourable outcomes were observed at one year in both treatment groups.Trial registration ClinicalTrials.gov NCT02006901.

Publication types

Comparative Study
Multicenter Study
Pragmatic Clinical Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Aged
Aged, 80 and over
Comparative Effectiveness Research
Decompression, Surgical / methods*
Disability Evaluation
Female
Humans
Laminectomy*
Lumbar Vertebrae / surgery*
Male
Middle Aged
Minimally Invasive Surgical Procedures / methods*
Models, Statistical
Propensity Score
Prospective Studies
Quality of Life
Registries
Spinal Stenosis / surgery*
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT02006901