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

CornerLoc

Status: Enrolling

Conditions: Sacroiliac; Fusion; Sacroiliac Joint Dysfunction

Treatments: Device: TransLoc 3D SI Joint Fusion System

Study type: Observational

Funder types: Industry

Identifiers

NCT06487936

RELIEF-02-24

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 1 patient group

Implanted TransLoc 3D SIJ Fusion Patients

Description:

Patients who were diagnosed with sacroiliitis and were treated with the TransLoc 3D System ≥ 1 year ≤ 18 months at the time of consent.

Treatment:

Device: TransLoc 3D SI Joint Fusion System