Clinical trial NCT00869882: SPONGIT: Comparison of Two Surgical Approaches in the Treatment of Degenerative Spondylolysthesis
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Spondylolisthesis
Keywords: Spondylolisthesis
degeneration
spinal fusion
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2009-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 24 months after surgery
Secondary outcomes:
measure: Major complication (ie, life threatening haemorrhage, severe and persisting neurological worsening, deep infection) rate, and minor complication rate
timeFrame: within 24 months after surgery
measure: Success rate defined as both fusion and at least 3-degree increase of segmental lordosis angle
timeFrame: 6 and 12 months after surgery
measure: Lumbar and radicular pain outcome
timeFrame: 2, 6, 12 and 24 months after surgery
measure: Functional outcome: Oswestry Disability Index and modified Prolo Economic and Functional scores
timeFrame: 2, 6, 12 and 24 months after surgery
measure: Change of pelvic and radiological parameters (ie, lumbar lordosis angle, medial intervertebral space height
timeFrame: 2, 6, 12 and 24 months after surgery
measure: Quality of life outcome: SF-36
timeFrame: 2, 6, 12 and 24 months after surgery
measure: Per and post operative surgery parameters (ie, operative time, blood loss, hospitalization stay duration)
timeFrame: within hospital stay due to surgery
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Service de chirurgie orthopédique, Hôpital Pellegrin Tripode
Study officials:
affiliation: University Hospital Bordeaux, France
name: Patrick GUERIN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Bordeaux, France
name: Antoine BENARD, MD
role: STUDY_CHAIR
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