Evaluation of the IFuse Bedrock Technique in Association with Posterior Lumbosacral Fusion with Iliac Fixation.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY

The purpose of this study is to describe the impact of the iFuse Bedrock technique to decrease post-operative pains in patients who underwent multilevel posterior lumbosacral fusion.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Subject scheduled for open posterior lumbosacral arthrodesis (including at least the following three vertebrae: L4, L5 and S1) associated with a sacroiliac fusion procedure and iliac fixation (thoracolumbar fusion procedures extended to sacrum are eligible in the study);

• Insertion of at least 1 iFuse-3D implant according to the iFuse Bedrock technique (uni- and bilateral insertion are eligible);

• Subject who preoperatively responded positively to pain provocation tests for SIJ dysfunction with or without a positive SIJ infiltration test;

• Patient with a degenerative sacroiliac joint disease requested a fusion procedure;

Locations
Other Locations
France
Polyclinique Bordeaux Nord Aquitaine
RECRUITING
Bordeaux
Hôpitaux Universitaires de Marseille
RECRUITING
Marseille
Contact Information
Primary
Stéphane Bourret
s.bourret@bordeauxnord.com
+33(0)556437017
Backup
Lisa Boue
l.boue@bordeauxnord.com
+33(0)556437017
Time Frame
Start Date: 2022-06-10
Estimated Completion Date: 2026-04-01
Participants
Target number of participants: 50
Treatments
iFuse Bedrock technique
Multilevel lumbar fusion procedure with additional sacroiliac joint stabilization using the iFuse-3D system
Related Therapeutic Areas
Sponsors
Collaborators: SI-BONE, Inc.
Leads: Polyclinique Bordeaux Nord Aquitaine

This content was sourced from clinicaltrials.gov

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