Return to Clinical Trials Search Results

IlluminOss Device Global Registry a prospective, post-market, multi-center evaluation of the clinical outcomes of the IlluminOss Device.

The primary endpoint of this post market registry study is to provide real-world evidence on the Composite Safety Success rate to enable meaningful comparison to other similar procedures. The Composite Safety Success rate is defined as the absence of Reoperation, Revision, Failure of Fixation, Device Breakage, and Device Loosening at Month 12. Subjects who experience any of these events will be classified as failures of the primary composite safety endpoint. Subjects who do not experience the Composite Safety endpoint will be classified as success. Secondary Endpoints: 1. Assessment of Complications/adverse events 2. Successful device implantation 3. Evidence of fracture healing 4. Disability status 5. Return to work status 6. Discharge status 7. Patient Reported Outcomes a. VAS Pain b. VR-12 c. PROMIS Physical Function Optional Data- 1. Assessment of pharmaco-economic data 2. Radiographic (AP/lateral/oblique) data

Phase

Post-market

Recruitment Status

Current Studies