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

NCT06487936 | Recruiting FDA Device

• 1 other identifier: RELIEF-02-24
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Sacroiliac Joint Dysfunction; Sacroiliac; Fusion

Outcome Measures

Primary Outcomes (1)

• Patient Satisfaction Survey

  Patient satisfaction survey administered greater than 1 year post-op: satisfaction, functional improvement, and disability as it relates to their SI joint

  Prospective 12 to 18 months post surgery

Secondary Outcomes (4)

• Visual Analogue Scale (VAS) of pain

  Baseline up to 1 year post surgery

• Oswestry Disability Index (ODI)

  Baseline up to 1 year post surgery

• SAEs

  Time of surgery up to 90 days post surgery

• CT Scan Second Read (Radiological Overread)

  12 to 18 months post fusion surgery

Study Arms (1)

Implanted TransLoc 3D SIJ Fusion Patients

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

Device: TransLoc 3D SI Joint Fusion System

Interventions

TransLoc 3D SI Joint Fusion System DEVICE

Satisfaction survey will be administered to collect real world evidence on patients that previously received the TransLoc 3D System commercially.

Implanted TransLoc 3D SIJ Fusion Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have already received the TransLoc 3D System \> 1 year postoperatively \< 18 months, at the time of consent.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CornerLoc: lead

Study Sites (1)

Advanced Orthopedic Center

Port Charlotte, Florida, 33948, United States

RECRUITING

Study Officials

• Lee James, DO

  Advanced Orthopedic Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carley Wiegner

CONTACT

888-743-8736; carley@cornerloc.com

Bob Compton

CONTACT

bob@cornerloc.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 18 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 5, 2024
• Study Start: August 15, 2024
• Primary Completion: October 15, 2024
• Study Completion: December 15, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)