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
198 weeks
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
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.
CONDITIONS
Official 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 L4, L5, and S1 vertebrae with sacroiliac fusion and iliac fixation
- At least one iFuse-3D implant inserted using the iFuse Bedrock technique
- Positive preoperative pain provocation tests for sacroiliac joint dysfunction, with or without positive SIJ infiltration test
- Diagnosed with degenerative sacroiliac joint disease requiring fusion procedure
You will not qualify if you...
- Major osteoporosis (DEXA scan > 3)
- Previous sacroiliac joint fusion or surgery involving S2-iliac fusion
- SIJ fusion requested without iFuse-3D device or incorrect iFuse-3D insertion
- Medical or surgical contraindications such as 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
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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
CONTACT
L
Lisa Boue
CONTACT
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
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