RecruitingNCT05276024

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


Sponsor

Polyclinique Bordeaux Nord Aquitaine

Enrollment

50 participants

Start Date

Jun 10, 2022

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates a new spinal fusion technique called the iFuse Bedrock technique, which uses a specific implant to stabilize the sacroiliac joint (the joint between the spine and pelvis) during complex lower back fusion surgeries. You may be eligible if: - You are 18 years or older - You are scheduled for open posterior lumbosacral fusion including L4, L5, and S1 with sacroiliac joint fusion and iliac fixation - You have at least one iFuse-3D implant placed using the Bedrock technique - You had positive pain provocation tests for sacroiliac joint dysfunction - You have degenerative sacroiliac joint disease requiring fusion You may NOT be eligible if: - You have severe osteoporosis (DEXA score above -3) - You have had prior sacroiliac joint fusion or S2-iliac surgery - You are not receiving the iFuse-3D implant or it is not placed using the Bedrock technique - You have neurological conditions, local or systemic infection, or allergy to implants - You are pregnant or planning pregnancy - You are a prisoner or ward of the state Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEiFuse Bedrock technique

Lumbosacral arthrodesis on 2 or more spinal segments (including at least L4, L5 and S1 vertebrae) associated with a sacroiliac fusion procedure according to the Bedrock technique using the iFuse 3D system and iliac fixation.


Locations(2)

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, France

Hôpitaux Universitaires de Marseille

Marseille, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05276024


Related Trials