Recruiting

TransLoc 3D

Sponsor:

CornerLoc

Code:

NCT06487936

Conditions

Sacroiliac Joint Dysfunction

Sacroiliac; Fusion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TransLoc 3D SI Joint Fusion System

Study Details

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

Study ID

NCT06487936

Start date

Aug 15, 2024

Status verified date

Aug, 2024

Completion date

Dec 15, 2024

Anticipated

Primary completion date

Oct 15, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Patient Satisfaction Survey [ Time Frame: Prospective 12 to 18 months post surgery ]

Central Contacts and Locations

Central contacts

Carley Wiegner

888-743-8736carley@cornerloc.com

Bob Compton

bob@cornerloc.com

Locations

Advanced Orthopedic Center

Recruiting

Port Charlotte, Florida, United States, 33948

More Information

Sponsor

CornerLoc

Last update posted

Aug 23, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CornerLoc on 2024-08-23.