Comparison of 3 Different Minimally Invasive Surgical Techniques for Lumbar Spinal Stenosis: A Randomized Clinical Trial.


Journal

JAMA network open
ISSN: 2574-3805
Titre abrégé: JAMA Netw Open
Pays: United States
ID NLM: 101729235

Informations de publication

Date de publication:
01 03 2022
Historique:
entrez: 28 3 2022
pubmed: 29 3 2022
medline: 15 4 2022
Statut: epublish

Résumé

Operations for lumbar spinal stenosis is the most often performed surgical procedure in the adult lumbar spine. This study reports the clinical outcome of the 3 most commonly used minimally invasive posterior decompression techniques. To compare the effectiveness of 3 minimally invasive posterior decompression techniques for lumbar spinal stenosis. This randomized clinical trial used a parallel group design and included patients with symptomatic and radiologically verified lumbar spinal stenosis without degenerative spondylolisthesis. Patients were enrolled between February 2014 and October 2018 at the orthopedic and neurosurgical departments of 16 Norwegian public hospitals. Statistical analysis was performed in the period from May to June 2021. Patients were randomized to undergo 1 of the 3 minimally invasive posterior decompression techniques: unilateral laminotomy with crossover, bilateral laminotomy, and spinous process osteotomy. Primary outcome was change in disability measured with Oswestry Disability Index (ODI; range 0-100), presented as mean change from baseline to 2-year follow-up and proportions of patients classified as success (>30% reduction in ODI). Secondary outcomes were mean change in quality of life, disease-specific symptom severity measured with Zurich Claudication Questionnaire (ZCQ), back pain and leg pain on a 10-point numeric rating score (NRS), patient perceived benefit of the surgical procedure, duration of the surgical procedure, blood loss, perioperative complications, number of reoperations, and length of hospital stay. In total, 437 patients were included with a median (IQR) age of 68 (62-73) years and 230 men (53%). Of the included patients, 146 were randomized to unilateral laminotomy with crossover, 142 to bilateral laminotomy, and 149 to spinous process osteotomy. The unilateral laminotomy with crossover group had a mean change of -17.9 ODI points (95% CI, -20.8 to -14.9), the bilateral laminotomy group had a mean change of -19.7 ODI points (95% CI, -22.7 to -16.8), and the spinous process osteotomy group had a mean change of -19.9 ODI points (95% CI, -22.8 to -17.0). There were no significant differences in primary or secondary outcomes among the 3 surgical procedures, except a longer duration of the surgical procedure in the bilateral laminotomy group. No differences in clinical outcomes or complication rates were found among the 3 minimally invasive posterior decompression techniques used to treat patients with lumbar spinal stenosis. ClinicalTrials.gov Identifier: NCT02007083.

Identifiants

pubmed: 35344046
pii: 2790425
doi: 10.1001/jamanetworkopen.2022.4291
pmc: PMC8961320
doi:

Banques de données

ClinicalTrials.gov
['NCT02007083']

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e224291

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Auteurs

Erland Hermansen (E)

Department of Orthopedic Surgery, Ålesund Hospital, Møre and Romsdal Hospital Trust, Ålesund, Norway.
Kysthospitalet in Hagevik, Orthopedic Clinic, Haukeland University Hospital, Bergen, Norway.
Department of Clinical Medicine, University of Bergen, Bergen, Norway.
Hofseth BioCare, Ålesund, Norway.

Ivar Magne Austevoll (IM)

Kysthospitalet in Hagevik, Orthopedic Clinic, Haukeland University Hospital, Bergen, Norway.

Christian Hellum (C)

Division of Orthopedic Surgery, Oslo University Hospital Ullevål, Oslo, Norway.

Kjersti Storheim (K)

Communication and Research Unit for Musculoskeletal Health (FORMI), Oslo University Hospital, Oslo, Norway.

Tor Åge Myklebust (TÅ)

Department of Research and Innovation, Møre and Romsdal Hospital Trust, Ålesund, Norway.
Department of Registration, Cancer Registry Norway, Oslo, Norway.

Jørn Aaen (J)

Department of Orthopedic Surgery, Ålesund Hospital, Møre and Romsdal Hospital Trust, Ålesund, Norway.
Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.

Hasan Banitalebi (H)

Department of Diagnostic Imaging, Akershus University Hospital, Oslo, Norway.
Institute of Clinical Medicine, University of Oslo, Oslo, Norway.

Masoud Anvar (M)

Unilabs Radiology, Oslo, Norway.

Frode Rekeland (F)

Kysthospitalet in Hagevik, Orthopedic Clinic, Haukeland University Hospital, Bergen, Norway.

Jens Ivar Brox (JI)

Department of Physical Medicine and Rehabilitation, Oslo University Hospital, Oslo, Norway.

Eric Franssen (E)

Department of Orthopedics, Stavanger University Hospital, Stavanger, Norway.

Clemens Weber (C)

Department of Orthopedics, Stavanger University Hospital, Stavanger, Norway.
Department of Neurosurgery, Stavanger University Hospital, Stavanger, Norway.
Department of Quality and Health Technology, University of Stavanger, Stavanger, Norway.

Tore K Solberg (TK)

Department of Neurosurgery and the Norwegian Registry for Spine Surgery, University Hospital of Northern Norway, Tromsø, Norway.
Institute of Clinical Medicine, The Arctic University of Norway, Tromsø, Norway.

Håvard Furunes (H)

Department of Surgery, Gjøvik Hospital, Innlandet Hospital Trust, Brumunddal, Norway.
Institute of Health and Society Studies, University of Oslo, Oslo, Norway.

Oliver Grundnes (O)

Department of Orthopedics, Akershus University Hospital, Oslo, Norway.

Helena Brisby (H)

Department of Orthopedics, Sahlgrenska University Hospital, Gothenburg, Sweden.
Department of Orthopedics, Institute for Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.

Kari Indrekvam (K)

Kysthospitalet in Hagevik, Orthopedic Clinic, Haukeland University Hospital, Bergen, Norway.
Department of Clinical Medicine, University of Bergen, Bergen, Norway.

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Classifications MeSH