Evaluating a technique to reduce post-operative pain after spine surgery

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

This study is testing a new technique to see if it can help people feel less pain after having spine surgery.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Polyclinique Bordeaux Nord Aquitaine (Academic / other)
• Locations: 2 sites (Bordeaux and 1 other locations)
• Trial ID: NCT05276024 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the effectiveness of the iFuse Bedrock technique in reducing post-operative pain in patients undergoing multilevel posterior lumbosacral fusion. It involves monitoring patients for lumbar and sacroiliac joint pain using various pain assessment tools over a 12-month period. Additionally, a CT scan will be performed at the end of the study to check for any complications related to the iFuse system. The study is multicentric and includes multiple medical centers to gather a diverse patient population.

Who should consider this trial

Good fit: Ideal candidates are patients scheduled for open posterior lumbosacral fusion who have sacroiliac joint dysfunction and meet specific inclusion criteria.

Not a fit: Patients with major osteoporosis or those who have previously undergone sacroiliac joint fusion may not benefit from this study.

Why it matters

Potential benefit: If successful, this technique could significantly reduce post-operative pain for patients undergoing complex spine surgeries.

How similar studies have performed: While this approach is innovative, similar techniques have shown promise in reducing post-operative pain in other surgical contexts.

Eligibility criteria

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.

Where this trial is running

Bordeaux and 1 other locations

• Polyclinique Bordeaux Nord Aquitaine — Bordeaux, France (Recruiting)
• Hôpitaux Universitaires de Marseille — Marseille, France (Recruiting)

Study contacts

• Principal investigator: Jean Charles Le Huec, M.D., PhD — VERTEBRA Institute, Polyclinique Bordeaux Nord Aquitaine
• Study coordinator: Stéphane Bourret

Conditions Sacroiliitis; Sacroiliac; Fusion; Lumbosacral; Spine Deformity; Sacroiliac joint pain; Sacroiliac joint fusion; Bedrock technique