Recruiting NCT06487936
Real-World Registry Study on Patient Satisfaction With TransLoc 3D SI Joint Fusion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TransLoc 3D SI Joint Fusion System.
- Who it may be relevant to
- Registry conditions: Sacroiliac Joint Dysfunction, Sacroiliac; Fusion. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multi-Center, Real World Prospective/Retrospective Registry to Evaluate Patient Satisfaction With the TransLoc 3D SI Joint Fusion System
Overview
This is a multi-center, consecutive enrollment registry study to evaluate patient satisfaction post SI Fusion with the TransLoc 3D SI Fusion System.
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.
Primary outcome measures
- Patient Satisfaction Survey [Time frame: Prospective 12 to 18 months post surgery]
Secondary outcome measures (4)
- Visual Analogue Scale (VAS) of pain [Time frame: Baseline up to 1 year post surgery]
- Oswestry Disability Index (ODI) [Time frame: Baseline up to 1 year post surgery]
- SAEs [Time frame: Time of surgery up to 90 days post surgery]
- CT Scan Second Read (Radiological Overread) [Time frame: 12 to 18 months post fusion surgery]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Advanced Orthopedic Center — Port Charlotte
Identifiers
NCT: NCT06487936 · RELIEF-02-24