An observational study in Sacroiliac Joint Dysfunction and Sacroiliac; Fusion, sponsored by CornerLoc. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-23.
Sponsored by CornerLoc · Observational
This is a multi-center, consecutive enrollment registry study to evaluate patient satisfaction post SI Fusion with the TransLoc 3D SI Fusion System.
CornerLoc is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who have already received the TransLoc 3D System > 1 year postoperatively \< 18 months, at the time of consent.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who were diagnosed with sacroiliitis and were treated with the TransLoc 3D System ≥ 1 year ≤ 18 months at the time of consent.
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.
Patient Satisfaction Survey
Patient satisfaction survey administered greater than 1 year post-op: satisfaction, functional improvement, and disability as it relates to their SI joint
Time frame: Prospective 12 to 18 months post surgery
Visual Analogue Scale (VAS) of pain
Retrospective analysis of VAS pre and post surgery, if available
Time frame: Baseline up to 1 year post surgery
Oswestry Disability Index (ODI)
Retrospective analysis of ODI pre and post surgery, if available
Time frame: Baseline up to 1 year post surgery
SAEs
Retrospective capture of Serious Adverse Events (SAEs) from the time of SI Fusion up to 90 days post operatively that required re-operation or in-patient hospitalization.
Time frame: Time of surgery up to 90 days post surgery
CT Scan Second Read (Radiological Overread)
CT scan for placement and fusion
Time frame: 12 to 18 months post fusion surgery
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.