Clinical Trial Finder

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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06487936
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 CornerLoc
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Lee James, DO
Principal Investigator Affiliation Advanced Orthopedic Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Sacroiliac Joint Dysfunction, Sacroiliac; Fusion
Arms & Interventions

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

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Advanced Orthopedic Center, Port Charlotte, Florida

Status

Recruiting

Address

Advanced Orthopedic Center

Port Charlotte, Florida, 33948

Site Contact

Lee James, DO

[email protected]

888-743-8736

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