SPONGIT: Comparison of Two Surgical Approaches in the Treatment of Degenerative Spondylolysthesis (SPONGIT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00869882|
Recruitment Status : Completed
First Posted : March 26, 2009
Last Update Posted : October 30, 2014
|Condition or disease||Intervention/treatment|
|Degenerative Spondylolisthesis||Procedure: Circumferential arthrodesis Procedure: Posterolateral fusion with instrumentation|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||June 2009|
|Primary Completion Date :||November 2013|
|Study Completion Date :||November 2013|
Posterolateral fusion with instrumentation combined to transforaminal lumbar interbody fusion
Procedure: Circumferential arthrodesis
Patients are carefully positioned in the proned position and submitted to a posterior surgical approach under general anaesthesia. Surgical levels are viewed laterally by mean of intraoperative radiographs which can be performed at surgeon's demand during the whole surgery time.
The preceding procedure is performed. In case of foraminal stenosis, decompression is performed at the same time as discal approach via the narrowest foramen.
In addition to this, before preparation of bed for bone grafting, nerve roots are retracted and the disc nucleus is removed entirely, then endplate decortication is performed. The disc space is distracted. The most anterior part of the disc space is packed with cancellous bone. A cage packed with bone is inserted into the anterior portion of the interspace. According to cage location, bone graft could be inserted in the posterior portion of the interspace. Cage placement is radiologically checked.
The end of the procedure is the same as for GPLI.
Other Name: TLIF+GPLI
Active Comparator: 2
Posterolateral fusion with instrumentation
Procedure: Posterolateral fusion with instrumentation
Patients are carefully positioned in pronation and submitted to a posterior surgical approach under general anaesthesia. Surgical levels are viewed laterally by mean of intraoperative radiographs performed at surgeon's demand during the whole surgery time.
Pedicle screw instrumentation is performed, followed by posterior neural decompression depending on the type of stenosis:
Subperiosteal dissection is performed between the transverse processes and lateral aspects of the facet joints.
Two rods are placed and locked on screws in maximum compression to optimize segmental lordosis.
Bone autograft is placed into this bed.
Other Name: GPLI
- 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 [ Time Frame: 24 months after surgery ]
- Major complication (ie, life threatening haemorrhage, severe and persisting neurological worsening, deep infection) rate, and minor complication rate [ Time Frame: within 24 months after surgery ]
- Success rate defined as both fusion and at least 3-degree increase of segmental lordosis angle [ Time Frame: 6 and 12 months after surgery ]
- Lumbar and radicular pain outcome [ Time Frame: 2, 6, 12 and 24 months after surgery ]
- Functional outcome: Oswestry Disability Index and modified Prolo Economic and Functional scores [ Time Frame: 2, 6, 12 and 24 months after surgery ]
- Change of pelvic and radiological parameters (ie, lumbar lordosis angle, medial intervertebral space height [ Time Frame: 2, 6, 12 and 24 months after surgery ]
- Quality of life outcome: SF-36 [ Time Frame: 2, 6, 12 and 24 months after surgery ]
- Per and post operative surgery parameters (ie, operative time, blood loss, hospitalization stay duration) [ Time Frame: within hospital stay due to surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00869882
|Service de chirurgie orthopédique, Hôpital Pellegrin Tripode|
|Bordeaux, France, 33076|
|Principal Investigator:||Patrick GUERIN, MD||University Hospital Bordeaux, France|
|Study Chair:||Antoine BENARD, MD||University Hospital Bordeaux, France|