Comparative Effectiveness of Microdecompression and Laminectomy for Central Lumbar Spinal Stenosis

Comparative Effectiveness of Microdecompression and Laminectomy for Central Lumbar Spinal Stenosis - An Observational Study

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).

Study Overview

• Status: Completed
• Conditions: Spinal Stenosis; Spinal Cord Compression
• Intervention / Treatment: Procedure: microdecompression; Procedure: laminectomy

• Study Type: Observational
• Enrollment (Actual): 721

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • St.Olavs Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; a minimal invasive surgical technique
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; The traditional open surgical technique: decompression with removal of the spinous process, lamina and often the medial facets

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Norwegian University of Science and Technology
• Investigators: Principal Investigator: Sasha Gulati, MD, PhD, St. Olavs Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ACTUAL): January 1, 2015
• Study Completion (ACTUAL): January 1, 2015

Study Registration Dates

• First Submitted: December 2, 2013
• First Submitted That Met QC Criteria: December 5, 2013
• First Posted (ESTIMATE): December 10, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): April 8, 2015
• Last Update Submitted That Met QC Criteria: April 7, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: registries; laminectomy; lumbar vertebrae; surgical procedures, operative; decompression, surgical; microdecompression
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Cord Diseases; Spinal Diseases; Bone Diseases; Spinal Cord Injuries; Constriction, Pathologic; Spinal Stenosis; Spinal Cord Compression
• Other Study ID Numbers: 2013/643