SPONGIT: Comparison of Two Surgical Approaches in the Treatment of Degenerative Spondylolysthesis (NCT00869882) | Clinical Trial Compass
CompletedNot Applicable
SPONGIT: Comparison of Two Surgical Approaches in the Treatment of Degenerative Spondylolysthesis
France60 participantsStarted 2009-06
Plain-language summary
This trial, conducted in adult patients with degenerative spondylolisthesis needing surgical treatment at one level, aimed at comparing two approaches of spinal fusion.
Who can participate
Age range18 Years – 74 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
What they're measuring
1
Success rate defined as fusion associated to at least a 3-degree increase of segmental lordosis angle and the absence of a reintervention due to a failure of the initial intervention