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

This is a multi-center, consecutive enrollment registry study to evaluate patient satisfaction post SI Fusion with the TransLoc 3D SI Fusion System.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-24
• Study First Submitted QC: 2024-06-27
• Study First Posted: 2024-07-05
• Status Verified: 2024-08
• Study Start: 2024-08-15
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23
• Primary Completion: 2024-10-15
• Study Completion: 2024-12-15

Recruitment & Eligibility

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

Inclusion Criteria

• 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 ≥1 year per standard of care

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction Survey	Prospective 12 to 18 months post surgery	Patient satisfaction survey administered greater than 1 year post-op: satisfaction, functional improvement, and disability as it relates to their SI joint

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS) of pain	Baseline up to 1 year post surgery	Retrospective analysis of VAS pre and post surgery, if available
Oswestry Disability Index (ODI)	Baseline up to 1 year post surgery	Retrospective analysis of ODI pre and post surgery, if available
CT Scan Second Read (Radiological Overread)	12 to 18 months post fusion surgery	CT scan for placement and fusion
SAEs	Time of surgery up to 90 days post surgery	Retrospective capture of Serious Adverse Events (SAEs) from the time of SI Fusion up to 90 days post operatively that required re-operation or in-patient hospitalization.

Trial Locations

Locations (1)

Advanced Orthopedic Center; 🇺🇸 Port Charlotte, Florida, United States