Real-World Registry Study on Patient Satisfaction With TransLoc 3D SI Joint Fusion
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCornerLoc
About this trial
This is a multi-center, consecutive enrollment registry study to evaluate patient satisfaction post SI Fusion with the TransLoc 3D SI Fusion System.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients who have already received the TransLoc 3D System \> 1 year postoperatively \< 18 months, at the time of consent.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
TransLoc 3D SI Joint Fusion System
DeviceSatisfaction survey will be administered to collect real world evidence on patients that previously received the TransLoc 3D System commercially.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Implanted TransLoc 3D SIJ Fusion Patients1 intervention
Trial outcomes
Primary outcomes
1
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 surgerySecondary outcomes
1
Visual Analogue Scale (VAS) of pain
Retrospective analysis of VAS pre and post surgery, if available
Time frame
Baseline up to 1 year post surgery2
Oswestry Disability Index (ODI)
Retrospective analysis of ODI pre and post surgery, if available
Time frame
Baseline up to 1 year post surgery3
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 surgery4
CT Scan Second Read (Radiological Overread)
CT scan for placement and fusion
Time frame
12 to 18 months post fusion surgery Source ClinicalTrials.gov