Real-World Registry Study on Patient Satisfaction With TransLoc 3D SI Joint Fusion

Recruiting

• Conditions: Sacroiliac Joint Dysfunction; Sacroiliac; Fusion

• Registration Number: NCT06487936
• Lead Sponsor: CornerLoc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-6-24
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Inclusion Criteria:<br><br> - Age 18 year or older<br><br> - Confirmed Implant of the Transloc 3D Fusion System<br><br> - Did not have Transloc device removed or another manufacturer device implanted post<br> Transloc<br><br> - Does not have other manufacturer's titanium or metal implant<br><br> - Patient may be included with prior allograft implant<br><br> - Willing to participate and give written consent<br><br> - Must have or planned CT post =1 year per standard of care<br><br>Exclusion Criteria:<br><br> - Patient is younger than 18 years<br><br> - Patient is unable to sign the Informed Consent<br><br> - Implant of other manufacturer's titanium or alternative metal implant<br><br> - Revision with another manufacturer's implant<br><br> - Fracture or unresolved trauma of implant side after implantation of TransLoc<br><br> - Patient unwilling to participate in Patient Satisfaction Survey<br><br> - Patient has not returned for Standard of Care follow-up

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational [Patient Registry]
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction Survey

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS) of pain;Oswestry Disability Index (ODI);SAEs;CT Scan Second Read (Radiological Overread)