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Implanted TransLoc 3D SIJ Fusion Patients for Sacroiliac Fusion (RELIEF Trial)
N/A
Recruiting
Led By Lee James, DO
Research Sponsored by CornerLoc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 1 year post surgery
Awards & highlights
No Placebo-Only Group
Summary
This is a multi-center, consecutive enrollment registry study to evaluate patient satisfaction post SI Fusion with the TransLoc 3D SI Fusion System.
Eligible Conditions
- Sacroiliac Fusion
- Sacroiliac Joint Dysfunction
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 1 year post surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 1 year post surgery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Patient Satisfaction Survey
Secondary study objectives
CT Scan Second Read (Radiological Overread)
Oswestry Disability Index (ODI)
SAEs
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Implanted TransLoc 3D SIJ Fusion PatientsExperimental Treatment1 Intervention
Patients who were diagnosed with sacroiliitis and were treated with the TransLoc 3D System ≥ 1 year ≤ 18 months at the time of consent.
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Who is running the clinical trial?
CornerLocLead Sponsor
2 Previous Clinical Trials
247 Total Patients Enrolled
Lee James, DOPrincipal InvestigatorAdvanced Orthopedic Center
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