Evaluating patient satisfaction after SI joint fusion with TransLoc 3D system
A Multi-Center, Real World Prospective/Retrospective Registry to Evaluate Patient Satisfaction With the TransLoc 3D SI Joint Fusion System
This study is testing how satisfied people are after having surgery with the TransLoc 3D system for their sacroiliac joint problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CornerLoc Industry-sponsored |
| Locations | 1 site (Port Charlotte, Florida) |
| Trial ID | NCT06487936 on ClinicalTrials.gov |
What this trial studies
This observational registry study aims to assess patient satisfaction following the implantation of the TransLoc 3D SI Fusion System for sacroiliac joint dysfunction. It involves multi-center consecutive enrollment of patients who have undergone this specific fusion procedure. Participants will be monitored for their satisfaction levels post-surgery, with data collected through patient satisfaction surveys and standard follow-up care. The study will include patients aged 18 and older who meet specific eligibility criteria related to their surgical history and willingness to participate.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have received the TransLoc 3D Fusion System and are willing to participate in satisfaction surveys.
Not a fit: Patients who have undergone revision surgery with another manufacturer's implant or are unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into patient satisfaction and outcomes associated with the TransLoc 3D SI Fusion System.
How similar studies have performed: While this study focuses on patient satisfaction, similar observational studies on surgical outcomes have shown success in evaluating patient-reported outcomes.
Eligibility criteria
Show full 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
Where this trial is running
Port Charlotte, Florida
- Advanced Orthopedic Center — Port Charlotte, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Lee James, DO — Advanced Orthopedic Center
- Study coordinator: Carley Wiegner
- Email: carley@cornerloc.com
- Phone: 888-743-8736
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.