Status:
UNKNOWN
Interbody vs Instrumented Posterolateral Fusion Following Decompression for Lumbar Spinal Stenosis With Degenerative Spondylolisthesis
Lead Sponsor:
The London Spine Centre
Conditions:
Degenerative Spondylolisthesis
Spinal Stenosis
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
Degenerative spondylolisthesis describes the slip of one spinal segment relative to the adjacent segment. It is usually associated with spinal stenosis (which limits one's ability to walk and stand) a...
Eligibility Criteria
Inclusion
- Patients aged 50 years or older
- Grade I or II (less than 50% slip of the cephalad vertebra compared to the caudal vertebra) degenerative spondylolisthesis at one or two contiguous levels between L1 and L5.
- Lumbar spinal stenosis at the same levels of the degenerative spondylolisthesis producing radiculopathy or neurogenic claudication unresponsive to a minimum of 3 months of non surgical treatment
- Patients who are medically suitable for surgical management
- Patients who have consented for surgical treatment
- Patients able to provide informed consent for the study and complete the questionnaires
Exclusion
- Lytic spondylolisthesis
- Non degenerative stenosis (example: tumor, trauma, epidural lipomatosis)
- Severe vertical foraminal stenosis necessitating interbody insertion to re-establish foraminal height
- Segmental kyphosis at the level of the spondylolisthesis
- Segmental scoliosis \>10 degrees at the level of the spondylolisthesis
- Rheumatoid arthritis
- Active infection
- On long term disability or workers compensation claim
- Drug or alcohol misuse
- Lack of permanent home residence
- Previous surgery at the proposed surgical level
- Previous fusion in the lumbar spine
- Contraindication to surgery: medical co morbidities
- Unable to complete questionnaire (e.g. Dementia)
- Unable to give voluntary consent
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT01921530
Start Date
December 1 2013
End Date
December 1 2019
Last Update
August 20 2018
Active Locations (1)
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1
London Health Sciences Centre
London, Ontario, Canada, N6G 5L7