SPONGIT: Comparison of Two Surgical Approaches in the Treatment of Degenerative Spondylolysthesis

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00869882
First received: March 25, 2009
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

This trial, conducted in adult patients with degenerative spondylolisthesis needing surgical treatment at one level, aimed at comparing two approaches of spinal fusion.


Condition Intervention
Degenerative Spondylolisthesis
Procedure: Circumferential arthrodesis
Procedure: Posterolateral fusion with instrumentation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Success rate defined as both fusion and at least 3-degree increase of segmental lordosis angle [ Time Frame: 6 and 12 months after surgery ] [ Designated as safety issue: No ]
  • Lumbar and radicular pain outcome [ Time Frame: 2, 6, 12 and 24 months after surgery ] [ Designated as safety issue: No ]
  • Functional outcome: Oswestry Disability Index and modified Prolo Economic and Functional scores [ Time Frame: 2, 6, 12 and 24 months after surgery ] [ Designated as safety issue: No ]
  • Change of pelvic and radiological parameters (ie, lumbar lordosis angle, medial intervertebral space height [ Time Frame: 2, 6, 12 and 24 months after surgery ] [ Designated as safety issue: No ]
  • Quality of life outcome: SF-36 [ Time Frame: 2, 6, 12 and 24 months after surgery ] [ Designated as safety issue: No ]
  • Per and post operative surgery parameters (ie, operative time, blood loss, hospitalization stay duration) [ Time Frame: within hospital stay due to surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: June 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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:

  • Central stenosis: decompression is performed including medial facectomy, laminectomy;
  • Foraminal stenosis: foraminotomy is performed, while preserving a graft bed as large as possible;
  • Pure foraminal stenosis: spinal duct is not opened. Local bone is harvested from the lamina and the spinous process and carefully fragmented for autologous graft.

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

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

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869882

Contacts
Contact: Patrick GUERIN, MD 33 05 56 79 87 19 patrick.guerin@chu-bordeaux.fr
Contact: Carole FABERES, MD 33 05 56 79 55 28/ 33 06 73 53 carolefaberes@yahoo.fr

Locations
France
Service de chirurgie orthopédique, Hôpital Pellegrin Tripode Recruiting
Bordeaux, France, 33076
Contact: Patrick GUERIN, MD    33 05 56 79 87 19    patrick.guerin@chu-bordeaux.fr   
Contact: Carole FABERES, MD    33 05 56 79 55 28    carolefaberes@yahoo.fr   
Principal Investigator: Patrick GUERIN, MD         
Sub-Investigator: Jean-Marc VITAL, Professor         
Sub-Investigator: Vincent POINTILLART, Professor         
Sub-Investigator: Olivier GILLE, Professor         
Sub-Investigator: Christophe CURSOLLE, MD         
Sub-Investigator: Stéphane LUC, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Patrick GUERIN, MD University Hospital Bordeaux, France
Study Chair: Antoine BENARD, MD University Hospital Bordeaux, France
  More Information

Publications:

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00869882     History of Changes
Other Study ID Numbers: CHUBX 2008/33
Study First Received: March 25, 2009
Last Updated: November 18, 2013
Health Authority: France: French Data Protection Authority

Keywords provided by University Hospital, Bordeaux:
Spondylolisthesis
degeneration
spinal fusion

Additional relevant MeSH terms:
Spondylolisthesis
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylolysis
Spondylosis

ClinicalTrials.gov processed this record on October 21, 2014