Actively Recruiting
A Multi-Center, Real World Prospective/Retrospective Registry to Evaluate Patient Satisfaction With the TransLoc 3D SI Joint Fusion System
Led by CornerLoc · Updated on 2024-08-23
120
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multi-center registry study to assess patient satisfaction following sacroiliac (SI) joint fusion using the TransLoc 3D SI Fusion System. This observational study aims to collect real-world data from patients who have undergone this procedure, focusing on their satisfaction with the device approximately one to one and a half years after surgery. The study includes patients diagnosed with sacroiliitis who received the TransLoc 3D System implant commercially and have had it in place for at least one year, up to 18 months at the time of consent. No new treatments are administered; instead, data is gathered through patient surveys and medical records, including CT scans performed as part of standard care. Participants will complete a patient satisfaction survey 12 to 18 months after surgery. Additional assessments include pain levels measured by the Visual Analogue Scale and disability measured by the Oswestry Disability Index, both recorded from baseline up to one year post-surgery. Safety is monitored through serious adverse events up to 90 days after surgery, and radiological evaluations occur between 12 and 18 months. The study relies on standard care follow-ups and lasts until data collection concludes in December 2024.
CONDITIONS
Brief Title
Real-World Registry Study on Patient Satisfaction With TransLoc 3D SI Joint Fusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 year or older
- Confirmed Implant of the Transloc 3D Fusion System
- Did not have Transloc device removed or another manufacturer device implanted post Transloc
- Does not have other manufacturer's titanium or metal implant
- Patient may be included with prior allograft implant
- Willing to participate and give written consent
- Must have or planned CT post 3 year per standard of care
You will not qualify if you...
- Patient is younger than 18 years
- Patient is unable to sign the Informed Consent
- Implant of other manufacturer's titanium or alternative metal implant
- Revision with another manufacturer's implant
- Fracture or unresolved trauma of implant side after implantation of TransLoc
- Patient unwilling to participate in Patient Satisfaction Survey
- Patient has not returned for Standard of Care follow-up
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 - Participants are observed 12 to 18 months post surgery
Participants who previously received the TransLoc 3D SI Joint Fusion System are included based on prior implantation.
1 to 2 visits depending on timing of CT scan and surveys
Duration - Up to 18 months post surgery
Participants complete patient satisfaction surveys and undergo assessments including pain and disability evaluations and radiological imaging as part of routine follow-up.
Approximately 2 visits during follow-up
Trial Site Locations
Total: 1 location
1
Advanced Orthopedic Center
Port Charlotte, Florida, United States, 33948
Actively Recruiting
Research Team
C
Carley Wiegner
B
Bob Compton
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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