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

Bordeaux Nord Aquitaine Group (GBNA)

Status

Enrolling

Conditions

Sacroiliac; Fusion

Lumbosacral; Fusion

Spine Deformity

Sacroiliitis

Treatments

Device: iFuse Bedrock technique

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05276024

2021-ORT03

Details and patient eligibility

About

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.

Full description

This study is a multicentric, post-marked clinical investigation to assess the efficacy of the iFuse Bedrock technique to avoid post-operative pains in patients who underwent open posterior multilevel lumbosacral fusion. Subjects will be monitored for lumbar pains (Oswestry score, VAS, SF-12 questionnaire) and sacroiliac joint pains (provocative tests) up to 12 months after initial procedure. A single CT-scan acquisition will be performed at 12 months to detect any iFuse system-related abnormality (implants loosening or breakages).

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.