Comparative Effectiveness of Microdecompression and Laminectomy for Central Lumbar Spinal Stenosis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT02006901
First received: December 2, 2013
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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).


Condition Intervention
Spinal Stenosis
Spinal Cord Compression
Procedure: microdecompression
Procedure: laminectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparative Effectiveness of Microdecompression and Laminectomy for Central Lumbar Spinal Stenosis - An Observational Study

Resource links provided by NLM:


Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:
  • change in Oswestry Disability Index [ Time Frame: between baseline and 12-months follow-up ] [ Designated as safety issue: No ]
    collected through the Norwegian Registry for Spine Surgery (NORspine)


Secondary Outcome Measures:
  • changes in health-related quality of life [ Time Frame: between baseline and 12-months follow-up ] [ Designated as safety issue: No ]
    measured by Euro-Qol-5D, collected through the Norwegian Registry for Spine Surgery (NORspine)

  • patient reported post-operative complications [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    wound infection, urinary tract infection, pneumonia, pulmonary embolism, and deep venous thrombosis

  • surgeon reported complication [ Time Frame: reported at discharge (expected average hospital stay of 3 days) ] [ Designated as safety issue: No ]
    intraoperative hemorrhage requiring blood replacement, unintentional durotomy, cardiovascular complications, respiratory complications, anaphylactic reactions, and wrong level surgery

  • Length of hospital stay [ Time Frame: reported at discharge (expected average hospital stay of 3 days) ] [ Designated as safety issue: No ]
    Length of hospital stay before discharge

  • Length of surgery [ Time Frame: reported at discharge (expected average hospital stay of 3 days) ] [ Designated as safety issue: No ]
    Length of surgery


Estimated Enrollment: 264
Study Start Date: January 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02006901

Locations
Norway
St.Olavs Hospital
Trondheim, Norway
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Investigators
Principal Investigator: Sasha Gulati, MD, PhD St. Olavs Hospital
  More Information

No publications provided

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT02006901     History of Changes
Other Study ID Numbers: 2013/643
Study First Received: December 2, 2013
Last Updated: March 4, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by St. Olavs Hospital:
surgical procedures, operative
lumbar vertebrae
decompression, surgical
microdecompression
laminectomy
registries

Additional relevant MeSH terms:
Constriction, Pathologic
Spinal Cord Compression
Spinal Stenosis
Pathological Conditions, Anatomical
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Injuries
Wounds and Injuries
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 29, 2014