Device Global Registry for the IlluminOss Bone Stabilization System

Pathological Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05206981
• Other study ID #: REP-2012
• Status: Recruiting
• Start date: June 11, 2021
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: IlluminOss Medical, Inc.
• Contact: Lisa Holt, PhD
• Phone: 401-714-0008
• Email: lholt[@]illuminoss.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Pathological Fracture
• Traumatic Fracture

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
IlluminOss Medical, Inc.

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Safety Success Rate		12 Months
Secondary	Complications/Adverse Events		12 Months
Secondary	Successful Device Implantation		12 Months
Secondary	Fracture Healing		12 Months
Secondary	Disability & Return to Work Status		12 Months
Secondary	Discharge Status		12 Months
Secondary	Visual Analog Pain Score		12 Months
Secondary	Veterans Rand 12 Item Health Survey		12 Months
Secondary	Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function		12 Months