Comparative Effectiveness of Microdecompression and Laminectomy for Central Lumbar Spinal Stenosis

Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02006901
• Other study ID #: 2013/643
• Status: Completed
• Phase: N/A
• First received: December 2, 2013
• Last updated: April 7, 2015
• Start date: January 2014
• Est. completion date: January 2015

Study information

• Verified date: April 2015
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 721
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Constriction, Pathologic
• Spinal Cord Compression
• Spinal Stenosis

Intervention

Procedure:
• microdecompression
a minimal invasive surgical technique
• laminectomy
The traditional open surgical technique: decompression with removal of the spinous process, lamina and often the medial facets

Locations

Country	Name	City	State
Norway	St.Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Nerland US, Jakola AS, Solheim O, Weber C, Rao V, Lønne G, Solberg TK, Salvesen Ø, Carlsen SM, Nygaard ØP, Gulati S. Minimally invasive decompression versus open laminectomy for central stenosis of the lumbar spine: pragmatic comparative effectiveness stu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in Oswestry Disability Index	collected through the Norwegian Registry for Spine Surgery (NORspine)	between baseline and 12-months follow-up	No
Secondary	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	No
Secondary	patient reported post-operative complications	wound infection, urinary tract infection, pneumonia, pulmonary embolism, and deep venous thrombosis	3 months	No
Secondary	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)	No
Secondary	Length of hospital stay	Length of hospital stay before discharge	reported at discharge (expected average hospital stay of 3 days)	No
Secondary	Length of surgery	Length of surgery	reported at discharge (expected average hospital stay of 3 days)	No