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

A Multi-Center, Real World Prospective/Retrospective Registry to Evaluate Patient Satisfaction With the TransLoc 3D SI Joint Fusion System

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

Study Overview

• Status: Recruiting
• Conditions: Sacroiliac Joint Dysfunction; Sacroiliac; Fusion
• Intervention / Treatment: Device: TransLoc 3D SI Joint Fusion System

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Carley Wiegner; Phone Number: 888-743-8736; Email: carley@cornerloc.com
• Study Contact Backup: Name: Bob Compton; Email: bob@cornerloc.com

Study Locations

• United States
  • Florida
    • Port Charlotte, Florida, United States, 33948
      • Recruiting
      • Advanced Orthopedic Center
      • Contact: Lee James, DO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Satisfaction survey will be administered to collect real world evidence on patients that previously received the TransLoc 3D System commercially.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS) of pain	Retrospective analysis of VAS pre and post surgery, if available	Baseline up to 1 year post surgery
Oswestry Disability Index (ODI)	Retrospective analysis of ODI pre and post surgery, if available	Baseline up to 1 year post surgery
SAEs	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.	Time of surgery up to 90 days post surgery
CT Scan Second Read (Radiological Overread)	CT scan for placement and fusion	12 to 18 months post fusion surgery

Collaborators and Investigators

• Sponsor: CornerLoc
• Investigators: Principal Investigator: Lee James, DO, Advanced Orthopedic Center

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2024
• Primary Completion (Estimated): October 15, 2024
• Study Completion (Estimated): December 15, 2024

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Ankylosis
• Other Study ID Numbers: RELIEF-02-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No