Comparative Effectiveness of Microdecompression and Laminectomy for Central Lumbar Spinal Stenosis

NCT02006901 | Completed

• 1 other identifier: 2013/643
• Study Type: observational
• Target: 721
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: This observational study is designed to test the equivalence between the clinical effectiveness of microdecompression and laminectomy in the surgical treatment of central lumbar spinal stenosis. Lumbar spinal stenosis is the most frequent indication for spinal surgery in the elderly, and as the oldest segment of the population continues to grow its prevalence is likely to increase. However, data on surgical outcomes are limited. Open or wide decompressive laminectomy, often combined with medial facetectomy and foraminotomy, was formerly the standard treatment. In recent years a growing tendency towards less invasive decompressive procedures has emerged. Many spine surgeons today perform microdecompression for central lumbar spinal stenosis. Prospectively registered treatment and outcome data are obtained from the Norwegian Registry for Spine Surgery (NORspine).

Conditions

Spinal Stenosis; Spinal Cord Compression

Keywords

surgical procedures, operative; lumbar vertebrae; decompression, surgical; microdecompression; laminectomy; registries

Outcome Measures

Primary Outcomes (1)

• change in Oswestry Disability Index

  collected through the Norwegian Registry for Spine Surgery (NORspine)

  between baseline and 12-months follow-up

Secondary Outcomes (5)

• changes in health-related quality of life

  between baseline and 12-months follow-up

• patient reported post-operative complications

  3 months

• surgeon reported complication

  reported at discharge (expected average hospital stay of 3 days)

• Length of hospital stay

  reported at discharge (expected average hospital stay of 3 days)

• Length of surgery

  reported at discharge (expected average hospital stay of 3 days)

Study Arms (2)

microdecompression

surgical microdecompression using a bilateral or unilateral approach depending on the surgeon's preference and the individual patient's anatomy and symptoms.

Procedure: microdecompression

laminectomy

the spinous process and the laminae of the involved level(s) as well as the medial aspects of the facet joints are resected

Procedure: laminectomy

Interventions

microdecompression PROCEDURE

a minimal invasive surgical technique

microdecompression

laminectomy PROCEDURE

The traditional open surgical technique: decompression with removal of the spinous process, lamina and often the medial facets

laminectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who had operation in ≤2 lumbar levels with either open decompressive laminectomy, bilateral microdecompression or unilateral microdecompression for bilateral decompression in Norway in the time period between October 2006 and December 2011

You may qualify if:

• Diagnosis of central lumbar spinal stenosis
• Operation in ≤2 lumbar levels with either open decompressive laminectomy, bilateral microdecompression or unilateral microdecompression for bilateral decompression in the time period between October 2006 and December 2011
• Included in the NORspine registry

You may not qualify if:

• History of lumbar fusion
• Previous surgery in the lumbar spine
• Discectomy as part of the decompression
• Associated pathological entities such as disc herniation, spondylolisthesis or scoliosis.

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

St.Olavs Hospital

Trondheim, Norway

Location

Related Publications (2)

• Nerland US, Jakola AS, Solheim O, Weber C, Rao V, Lonne G, Solberg TK, Salvesen O, Carlsen SM, Nygaard OP, Gulati S. 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.

  PMID: 25833966 RESULT

• Nerland US, Jakola AS, Solheim O, Weber C, Rao V, Lonne G, Solberg TK, Salvesen O, Carlsen SM, Nygaard OP, Gulati S. Comparative effectiveness of microdecompression and laminectomy for central lumbar spinal stenosis: study protocol for an observational study. BMJ Open. 2014 Mar 20;4(3):e004651. doi: 10.1136/bmjopen-2013-004651.

  PMID: 24650809 DERIVED

MeSH Terms

Conditions

Spinal Stenosis; Spinal Cord Compression

Interventions

Laminectomy

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Therapeutics; Decompression, Surgical; Surgical Procedures, Operative; Neurosurgical Procedures

Study Officials

• Sasha Gulati, MD, PhD

  St. Olavs Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 10, 2013
• Study Start: January 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: April 8, 2015

Record last verified: 2015-04

Locations

NO (1)