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

Sacroiliitis Spine Deformity Sacroiliac; Fusion Lumbosacral; Fusion

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

Inclusion Criteria4

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;

Exclusion Criteria8

Major osteoporosis (DEXA scan \> 3);
Any previous history of sacroiliac joint fusion or any surgical procedure involving a S2-iliac fusion;
Subjects requested a SIJ fusion without the iFuse-3D device or iFuse-3D not inserted according to the manufacturer instruction (Bedrock technique);
Subjects with a medical or surgical contraindication preventing the intervention from being performed or potentially interfering in the interpretation of the data collected (neurologic condition, local or systemic infection, any known allergy to surgical implants, psychiatric diseases, ...);
Currently pregnant or planning pregnancy;
Prisoner or a ward of the state;
Subject no willing to participate in the study;
Subject not affiliated to a social security insurance.

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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.