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

NCT00869882 | Completed

• 2 other identifiers: CHUBX 2008/332008-A01645-50
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Spondylolisthesis

Keywords

Spondylolisthesis; degeneration; spinal fusion

Outcome Measures

Primary Outcomes (1)

• 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

  24 months after surgery

Secondary Outcomes (7)

• Major complication (ie, life threatening haemorrhage, severe and persisting neurological worsening, deep infection) rate, and minor complication rate

  within 24 months after surgery

• Success rate defined as both fusion and at least 3-degree increase of segmental lordosis angle

  6 and 12 months after surgery

• Lumbar and radicular pain outcome

  2, 6, 12 and 24 months after surgery

• Functional outcome: Oswestry Disability Index and modified Prolo Economic and Functional scores

  2, 6, 12 and 24 months after surgery

• Change of pelvic and radiological parameters (ie, lumbar lordosis angle, medial intervertebral space height

  2, 6, 12 and 24 months after surgery

Study Arms (2)

1

EXPERIMENTAL

Posterolateral fusion with instrumentation combined to transforaminal lumbar interbody fusion

Procedure: Circumferential arthrodesis

2

ACTIVE COMPARATOR

Posterolateral fusion with instrumentation

Procedure: Posterolateral fusion with instrumentation

Interventions

Circumferential arthrodesis PROCEDURE

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.

Also known as: TLIF+GPLI

1

Posterolateral fusion with instrumentation PROCEDURE

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.

Also known as: GPLI

2

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Service de chirurgie orthopédique, Hôpital Pellegrin Tripode

Bordeaux, 33076, France

Location

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MeSH Terms

Conditions

Spondylolisthesis

Condition Hierarchy (Ancestors)

Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Patrick GUERIN, MD

  University Hospital Bordeaux, France

  PRINCIPAL INVESTIGATOR

• Antoine BENARD, MD

  University Hospital Bordeaux, France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2009
• First Posted: March 26, 2009
• Study Start: June 1, 2009
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: May 14, 2026

Record last verified: 2014-10

Locations

FR (1)