Comparative Effectiveness of Microdecompression and Laminectomy for Central Lumbar Spinal Stenosis

Completed

• Conditions: Spinal Stenosis; Spinal Cord Compression
• Interventions: Procedure: laminectomy; Procedure: microdecompression

• Registration Number: NCT02006901
• Lead Sponsor: St. Olavs Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-02
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-10
• Study Start: 2014-01
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 721

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
laminectomy	laminectomy	the spinous process and the laminae of the involved level(s) as well as the medial aspects of the facet joints are resected
microdecompression	microdecompression	surgical microdecompression using a bilateral or unilateral approach depending on the surgeon's preference and the individual patient's anatomy and symptoms.

Primary Outcome Measures

Name	Time	Method
change in Oswestry Disability Index	between baseline and 12-months follow-up	collected through the Norwegian Registry for Spine Surgery (NORspine)

Secondary Outcome Measures

Name	Time	Method
changes in health-related quality of life	between baseline and 12-months follow-up	measured by Euro-Qol-5D, collected through the Norwegian Registry for Spine Surgery (NORspine)
surgeon reported complication	reported at discharge (expected average hospital stay of 3 days)	intraoperative hemorrhage requiring blood replacement, unintentional durotomy, cardiovascular complications, respiratory complications, anaphylactic reactions, and wrong level surgery
patient reported post-operative complications	3 months	wound infection, urinary tract infection, pneumonia, pulmonary embolism, and deep venous thrombosis
Length of hospital stay	reported at discharge (expected average hospital stay of 3 days)	Length of hospital stay before discharge
Length of surgery	reported at discharge (expected average hospital stay of 3 days)	Length of surgery

Trial Locations

Locations (1)

St.Olavs Hospital; 🇳🇴 Trondheim, Norway