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

May 11, 2026 updated by: University Hospital, Bordeaux

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • Service de chirurgie orthopédique, Hôpital Pellegrin Tripode

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • GPLI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 months after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
6 and 12 months after surgery
Lumbar and radicular pain outcome
Time Frame: 2, 6, 12 and 24 months after surgery
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
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
2, 6, 12 and 24 months after surgery
Quality of life outcome: SF-36
Time Frame: 2, 6, 12 and 24 months after surgery
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
within hospital stay due to surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Patrick GUERIN, MD, University Hospital Bordeaux, France
  • Study Chair: Antoine BENARD, MD, University Hospital Bordeaux, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

March 25, 2009

First Submitted That Met QC Criteria

March 25, 2009

First Posted (Estimated)

March 26, 2009

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2008/33
  • 2008-A01645-50 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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