NCT05206981

Device Global Registry for the IlluminOss Bone Stabilization System

IlluminOss Device Global Registry - A Prospective, Post-Market, Multi-Center Evaluation of the Clinical Outcomes of the IlluminOss Device

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: IlluminOss Medical, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: —

Summary

This is a multi-center, observational patient registry. The primary objective of the study is to collect safety and performance data on the IlluminOss Device when used to provide stabilization and alignment for the treatment of traumatic or impending and pathologic fractures.

Detailed description

This is a registry database which will collect patient data as part of a physician's standard of care. Medical data will be collected on patients via questionnaires in either web based or paper forms. Both prospective and retrospective data will be entered into the database. Data collection will begin during the initial visit to the clinic. Demographic, surgical, hospital discharge, and adverse event data will be collected as well as patient reported outcomes including the PROMIS physical function, Visual Analog Pain Score (VAS), and Veterans Rand 12 (VR 12) surveys. Patients will be asked to complete these surveys at the pre-operative and post operative visits at 75 days, 6 months, and 12 months.

Conditions

• Traumatic Fracture
• Pathological Fracture

Interventions

Type	Name	Description
DEVICE	IlluminOss Device	Patients may enroll in the registry if they have been implanted (retrospective) or will be implanted (prospective) with the IlluminOss device.

Timeline

• Start date: 2021-06-11
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-01-25
• Last updated: 2026-04-17

Locations

16 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated device study