Degenerative Spondylolisthesis Clinical Trial
Official title:
Comparison of 2 Surgical Approaches in the Treatment of Degenerative Spondylolysthesis: Posterolateral Fusion With Instrumentation (GPLI) Plus or Minus Transforaminal Lumbar Interbody Fusion (TLIF)
This trial, conducted in adult patients with degenerative spondylolisthesis needing surgical treatment at one level, aimed at comparing two approaches of spinal fusion.
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 about 60. Surgery is indicated in the presence of radiculalgia and/or
neurological claudication and/or invalidating lombalgia, worsening neurological deficit,
presence of sphincterian incontinence.
Surgical treatment of degenerative spondylolisthesis usually consists in neural
decompression followed by posterolateral fusion with instrumentation. In the literature,
fusion rate is estimated to be 80% with GPLI and seems to be increased by interbody fusion,
especially transforaminal lumbar interbody fusion which has the advantage of unilateral disc
interspace route, and fusion rate over 90%.
It seems that hypolordosis in the instrumented segments caused increased loading of the
posterior column in the adjacent segments. These biomechanical effects may explain the
degenerative changes at the junction level that have been observed as long-term consequences
of lumbar fusion.
In addition to fusion, segmental lordosis gain seems to be an important long-term prognostic
factor. Segmental lordosis recovery (upper than 3° in order to take into account measurement
variability), was never assessed after TLIF procedure nor compared to that after
posterolateral fusion in controlled randomized clinical trials.
The main objective of the study is the comparison of efficacy between circumferential fusion
(TLIF plus GPLI) and GPLI alone as surgical treatment of degenerative spondylolisthesis in
term of "Success" rate, defined as fusion and at least 3-degree increase of segmental
lordosis angle, 24 months after surgery.
In this trial, included patients will be randomly assigned to undergo either posterolateral
fusion with instrumentation (GPLI) or circumferential fusion with transforaminal lumbar
interbody fusion (TLIF) combined to GPLI. In both arms, bone autograft will be performed
using loose fragments obtained during neurological decompression.
Six visits are planned during the study: pre-inclusion visit within 3 months before surgery,
inclusion/randomisation on the day before surgery, 3 follow-up visits (2, 6, and 12 months
after surgery) and an end of study visit 24 months after surgery (or at time of withdrawal
if relevant). Hospital stay (about one week, on average) is planned after surgery.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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