Comparative Effectiveness of Microdecompression and Laminectomy for Central Lumbar Spinal Stenosis
- Conditions
- Spinal StenosisSpinal Cord Compression
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 721
- 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
- 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
- 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)
patient reported post-operative complications 3 months wound infection, urinary tract infection, pneumonia, pulmonary embolism, and deep venous thrombosis
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
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
St.Olavs Hospital🇳🇴Trondheim, Norway