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

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ClinicalTrials.gov Identifier: NCT00869882
Recruitment Status : Completed
First Posted : March 26, 2009
Last Update Posted : October 30, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Tracking Information
First Submitted Date  ICMJE March 25, 2009
First Posted Date  ICMJE March 26, 2009
Last Update Posted Date October 30, 2014
Study Start Date  ICMJE June 2009
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2009)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 25, 2009)
Success rate defined as both fusion and at least 3 degree increase of segmental lordosis angle [ Time Frame: 24 months after surgery ]
Change History Complete list of historical versions of study NCT00869882 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SPONGIT: Comparison of Two Surgical Approaches in the Treatment of Degenerative Spondylolysthesis
Official Title  ICMJE Comparison of 2 Surgical Approaches in the Treatment of Degenerative Spondylolysthesis: Posterolateral Fusion With Instrumentation (GPLI) Plus or Minus Transforaminal Lumbar Interbody Fusion (TLIF)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Degenerative Spondylolisthesis
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: 1
    Posterolateral fusion with instrumentation combined to transforaminal lumbar interbody fusion
    Intervention: Procedure: Circumferential arthrodesis
  • Active Comparator: 2
    Posterolateral fusion with instrumentation
    Intervention: Procedure: Posterolateral fusion with instrumentation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2014)
60
Original Estimated Enrollment  ICMJE
 (submitted: March 25, 2009)
70
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00869882
Other Study ID Numbers  ICMJE CHUBX 2008/33
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Bordeaux
Study Sponsor  ICMJE University Hospital, Bordeaux
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Patrick GUERIN, MD University Hospital Bordeaux, France
Study Chair: Antoine BENARD, MD University Hospital Bordeaux, France
PRS Account University Hospital, Bordeaux
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP