MedTrace Logo

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

NCT00869882 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-14

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Patrick GUERIN, MD · University Hospital Bordeaux, France

  • Antoine BENARD, MD · University Hospital Bordeaux, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00869882 on ClinicalTrials.gov