Sacroiliac; Fusion, Sacroiliac Joint Dysfunction
Conditions
Brief summary
This is a multi-center, consecutive enrollment registry study to evaluate patient satisfaction post SI Fusion with the TransLoc 3D SI Fusion System.
Interventions
DEVICETransLoc 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.
Sponsors
CornerLoc
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Survey | Prospective 12 to 18 months post surgery | Patient satisfaction survey administered greater than 1 year post-op: satisfaction, functional improvement, and disability as it relates to their SI joint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) of pain | Baseline up to 1 year post surgery | Retrospective analysis of VAS pre and post surgery, if available |
| Oswestry Disability Index (ODI) | Baseline up to 1 year post surgery | Retrospective analysis of ODI pre and post surgery, if available |
| SAEs | Time of surgery up to 90 days post surgery | 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. |
| CT Scan Second Read (Radiological Overread) | 12 to 18 months post fusion surgery | CT scan for placement and fusion |
Countries
United States
Contacts
Primary ContactCarley Wiegner
Backup ContactBob Compton
Outcome results
None listed