Actively Recruiting
Global Patient Registry Evaluating Safety and Outcomes of the IlluminOss Bone Stabilization Device in Adults Over 50 with Traumatic or Pathologic Fractures
Led by IlluminOss Medical, Inc. · Updated on 2026-04-17
300
Participants Needed
16
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are gathering information on the IlluminOss Device, which is used to stabilize and align bones in patients with traumatic or pathological fractures. This multi-center, observational patient registry aims to collect safety and performance data on this device as part of standard medical care. The study includes patients aged 50 and older who are candidates for the device. Patients who have received or will receive the IlluminOss Device are included in the registry. Data collection starts at the initial clinic visit and includes both prospective and retrospective entries. Medical details, surgical information, hospital discharge data, and any adverse events are recorded. Participants will complete patient-reported surveys such as PROMIS physical function, Visual Analog Pain Score VAS, and Veterans Rand 12 VR 12 before surgery and at 75 days, 6 months, and 12 months after the procedure. Throughout the study, patients will undergo scheduled clinical and radiographic evaluations to monitor outcomes. Researchers will track safety success rates, complications, device implantation success, fracture healing, disability, return to work status, discharge status, and patient-reported outcomes over 12 months. The study is designed to observe real-world use of the device and its effects on patient recovery and function over time.
CONDITIONS
Brief Title
Device Global Registry for the IlluminOss Bone Stabilization System
Research Team
L
Lisa Holt, PhD
C
Caitlin Smith, MPH
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