Actively Recruiting
Evaluation of the IFuse Bedrock Technique in Association with Posterior Lumbosacral Fusion with Iliac Fixation
Led by Polyclinique Bordeaux Nord Aquitaine · Updated on 2024-11-08
50
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
P
Polyclinique Bordeaux Nord Aquitaine
Lead Sponsor
S
SI-BONE, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the iFuse Bedrock technique in patients undergoing multilevel posterior lumbosacral fusion to reduce post-operative pain. This multicenter clinical investigation aims to assess how this device-based method may impact lumbar and sacroiliac joint pain up to 12 months after surgery. The study focuses on patients with degenerative sacroiliac joint disease who require fusion procedures involving at least L4, L5, and S1 vertebrae. The treatment involves a multilevel lumbar fusion combined with sacroiliac joint stabilization using the iFuse-3D system following the Bedrock technique. Participants receive open posterior lumbosacral arthrodesis with iliac fixation and at least one iFuse-3D implant inserted unilaterally or bilaterally. The study includes a 12-month follow-up period during which patients are monitored clinically and radiologically. Participants will be followed for a full year after surgery, with lumbar pain assessed using tools like the Oswestry Disability Index, Visual Analog Scale, and SF-12 questionnaire. Sacroiliac joint pain will be evaluated with provocative tests, and a CT scan at 12 months will check for any implant-related issues. Researchers will collect data on pain changes, quality of life, spinal alignment, and any complications or adverse events related to the device.
CONDITIONS
Brief Title
Evaluation of the IFuse Bedrock Technique in Association with Posterior Lumbosacral Fusion with Iliac Fixation.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled for open posterior lumbosacral arthrodesis including at least L4, L5, and S1 vertebrae with sacroiliac fusion and iliac fixation
- At least one iFuse-3D implant inserted following the Bedrock technique (uni- or bilateral)
- Positive preoperative pain provocation tests for sacroiliac joint dysfunction
- Diagnosed with degenerative sacroiliac joint disease requiring fusion procedure
You will not qualify if you...
- Major osteoporosis (DEXA scan score greater than 3)
- Previous sacroiliac joint fusion or surgery involving S2-iliac fusion
- Sacroiliac fusion requested without iFuse-3D device or incorrect device insertion
- Medical or surgical contraindications to intervention (neurologic conditions, infections, allergies to implants, psychiatric diseases)
- Currently pregnant or planning pregnancy
- Prisoner or ward of the state
- Unwilling to participate
- Not affiliated with social security insurance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and immediate recovery period
Participants undergo the open posterior multilevel lumbosacral fusion with iliac fixation using the iFuse Bedrock technique.
1 surgery visit and hospital stay
Duration - Up to 12 months after surgery
Participants are monitored for lumbar and sacroiliac joint pains and implant-related outcomes.
Follow-up visits at 3, 6, and 12 months including questionnaires and assessments; 1 CT scan at 12 months
Trial Site Locations
Total: 2 locations
1
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France, 33300
Actively Recruiting
2
Hôpitaux Universitaires de Marseille
Marseille, France, 13005
Actively Recruiting
Research Team
S
Stéphane Bourret
L
Lisa Boue
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here