Device Global Registry for the IlluminOss Bone Stabilization System
Part of paid clinical trials in Mobile, Alabama.
- Sponsor
- IlluminOss Medical, Inc.
- Study ID
- NCT05206981
- Status
- Recruiting
Conditions
- Pathological Fracture
- Traumatic Fracture
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- IlluminOss Device — DEVICEPatients may enroll in the registry if they have been implanted (retrospective) or will be implanted (prospective) with the IlluminOss device.
Study Details
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.
Key Dates
- Start date
- Jun 11, 2021
- Status verified
- Apr 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 300 participants (estimated)
Primary Outcome Measure
Composite Safety Success Rate [ Time Frame: 12 Months ]
Central Contacts
- Lisa Holt, PhD401-714-0008
- Caitlin Smith, MPH401-714-0008
Locations (13)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Gulf Orthopedics | Mobile | Alabama | 36604 | - |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | Arman Jordan Charles Moon, MD (PRINCIPAL_INVESTIGATOR) |
| Presbyterian St Luke's Medical Ctr | Denver | Colorado | 80218 | Daniel Lerman, MD (PRINCIPAL_INVESTIGATOR) |
| University of Miami Hospital | Miami | Florida | 33136 | Anastasiya Drandarov Brooke Crawford, MD (PRINCIPAL_INVESTIGATOR) Marilyn Heng, MD (SUB_INVESTIGATOR) |
| Weston Outpatient Surgical Center | Weston | Florida | 33326 | David Shenassa, MD (PRINCIPAL_INVESTIGATOR) |
| Parkview Health | Fort Wayne | Indiana | 46845 | - |
| Jacobi Medical Center | The Bronx | New York | 10461 | Francisco Reinoso Milan Sen, MD (PRINCIPAL_INVESTIGATOR) |
| Mission Hospital | Asheville | North Carolina | 28801 | - |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | Ariel Brotherton Martha Holden Cynthia Emory, MD (PRINCIPAL_INVESTIGATOR) Jason Halvorson, MD (SUB_INVESTIGATOR) Holly Pilson, MD (SUB_INVESTIGATOR) |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | Kriti Rawat Theresa Pazionis (PRINCIPAL_INVESTIGATOR) |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | Beata Krawczyk Richard McGough, MD (PRINCIPAL_INVESTIGATOR) |
| Ortho Rhode Island | Wakefield | Rhode Island | 02879 | Jennifer Stedman Michael Bradley, MD (PRINCIPAL_INVESTIGATOR) Anthony DeLuise, MD (SUB_INVESTIGATOR) Keith Monchik, MD (SUB_INVESTIGATOR) |
| Memorial Hermann Hospital | Katy | Texas | 77494 | Sterling Boutte William Harvin, MD (PRINCIPAL_INVESTIGATOR) |
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