Status:
COMPLETED
SPONGIT: Comparison of Two Surgical Approaches in the Treatment of Degenerative Spondylolysthesis
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Degenerative Spondylolisthesis
Eligibility:
All Genders
18-74 years
Phase:
NA
Brief Summary
This trial, conducted in adult patients with degenerative spondylolisthesis needing surgical treatment at one level, aimed at comparing two approaches of spinal fusion.
Detailed Description
Degenerative spondylolisthesis is defined as the slip of one vertebra onto the other due to degenerative lesions; the L4-L5 intervertebral space is mainly involved. Mean age of symptomatic disease is ...
Eligibility Criteria
Inclusion
- Adults aged less than 75,
- Having been informed about clinical trial objectives and risk,
- Covered by health insurance system,
- Suffering from degenerative spondylolisthesis (whatever the grade and intervertebral disc height) needing one-level surgical fusion due to either invalidating lombalgia/radiculalgia despite 6-month optimal medical treatment and/or motor neurological symptoms.
Exclusion
- Previous lumbar fusion,
- Previous spine traumatism,
- Presence of at least one major contraindication to surgery and/or general anaesthesia (ie, non controlled coagulopathy, active infection, or serious underlying disease, auto-immune affection).
- Presence of at least one contraindication to either TLIF or GPLI,
- Severe radiological osteoporosis.
- Active cancer at time of inclusion into the study.
- Unlikely to comply with the requirements of the study and/or to complete the study for psychological, social, familial or geographical reasons.
- Under any administrative or legal supervision.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00869882
Start Date
June 1 2009
End Date
November 1 2013
Last Update
October 30 2014
Active Locations (1)
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1
Service de chirurgie orthopédique, Hôpital Pellegrin Tripode
Bordeaux, France, 33076