Device Global Registry for the IlluminOss Bone Stabilization System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-11

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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

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Traumatic Fracture Pathological Fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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IlluminOss Device

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

United States (U.S.)

This product is contraindicated in U.S. patients who have:

1. an active or incompletely treated infection that could involve the site where the device will be implanted;
2. are allergic to any of the implant materials or to dental glue;
3. have an intramedullary canal measuring smaller than the diameter of the delivery sheath provided at the site of the fracture;
4. distant foci of infections which may spread to the implant site, have open fractures with severe contamination;
5. 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:

1. Patients who are considered skeletally immature.
2. Presence of active or incompletely treated infections that could involve the site where the device will be implanted.
3. Patients allergic to any of the implant materials, or to dental glue.
4. Patients whose intramedullary canal at site of fracture measures smaller than the diameter of the sheath provided.
5. Uncooperative patient or patient with neurologic disorder, incapable of following directions.
6. Distant foci of infections which may spread to the implant site.
7. Vascular insufficiency.
8. Open fractures with severe contamination.
9. Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable.
10. Delivery sheath is unable to cross fracture site after proper fracture reduction and realignment.

For acute Humerus fractures:
11. Patients who are under the age of Fifty (50)

For all bones excluding pathologic Humerus:
12. Metabolic disorders which may impair bone formation.
13. Osteomalacia.
14. Vascular insufficiency, muscular atrophy, or neuro-muscular disease.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No