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

NCT ID: NCT06487936

Last Updated: 2024-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-15

Study Completion Date

2024-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sacroiliac Joint Dysfunction Sacroiliac; Fusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

TransLoc 3D SI Joint Fusion System

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

CornerLoc

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lee James, DO

Role: PRINCIPAL_INVESTIGATOR

Advanced Orthopedic Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Advanced Orthopedic Center

Port Charlotte, Florida, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Carley Wiegner

Role: CONTACT

888-743-8736

Bob Compton

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lee James, DO

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RELIEF-02-24

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Prospective SPINE Registry
NCT04176562 RECRUITING