Device Global Registry for the IlluminOss Bone Stabilization System

Recruiting now

Conditions studied: Traumatic Fracture, Pathological Fracture

In brief

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 facts

Study ID

NCT05206981

Run by

IlluminOss Medical, Inc.

People needed

300

Starts

2021-06-11

Expected to finish

2026-12-01

Last updated by the study team

2026-04-17

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient has been deemed a candidate for the IlluminOss device
• Patient is male or non-pregnant female
• Patient is willing and able to comply with the postoperative scheduled clinical and radiographic evaluations
• Patient is willing and able to give informed consent if required
• Traumatic patient is over the age of 50
• IlluminOss procedure is the initial procedure to treat the traumatic injury

You may not qualify if…

• United States (U.S.)
• This product is contraindicated in U.S. patients who have:
• an active or incompletely treated infection that could involve the site where the device will be implanted;
• are allergic to any of the implant materials or to dental glue;
• have an intramedullary canal measuring smaller than the diameter of the delivery sheath provided at the site of the fracture;
• distant foci of infections which may spread to the implant site, have open fractures with severe contamination;
• or in patients for whom delivery sheath is unable to cross fracture site after proper fracture reduction and realignment.
• European Union (EU)
• This product is contraindicated in EU patients who have:
• For all Bones:
• Patients who are considered skeletally immature.
• Presence of active or incompletely treated infections that could involve the site where the device will be implanted.
• Patients allergic to any of the implant materials, or to dental glue.
• Patients whose intramedullary canal at site of fracture measures smaller than the diameter of the sheath provided.
• Uncooperative patient or patient with neurologic disorder, incapable of following directions.
• Distant foci of infections which may spread to the implant site.
• Vascular insufficiency.
• Open fractures with severe contamination.
• Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable.
• Delivery sheath is unable to cross fracture site after proper fracture reduction and realignment.
• For acute Humerus fractures:
• Patients who are under the age of Fifty (50)
• For all bones excluding pathologic Humerus:
• Metabolic disorders which may impair bone formation.
• Osteomalacia.

Where it is running

• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (enrolling)
• Ortho Rhode Island — Wakefield, Rhode Island, United States (enrolling)
• Memorial Hermann Hospital — Katy, Texas, United States (enrolling)
• University of Miami Hospital — Miami, Florida, United States (enrolling)
• Weston Outpatient Surgical Center — Weston, Florida, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Jacobi Medical Center — The Bronx, New York, United States (enrolling)
• Presbyterian St Luke's Medical Ctr — Denver, Colorado, United States (enrolling)
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States (enrolling)
• Temple University Hospital — Philadelphia, Pennsylvania, United States (enrolling)
• Petrus Hospital — Wuppertal, Germany
• Parkview Health — Fort Wayne, Indiana, United States
• Mission Hospital — Asheville, North Carolina, United States
• St Vinzenz Hospital — Cologne, Germany
• Johannes Wesling Hospital Minden — Minden, Germany
• Gulf Orthopedics — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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