Clinical trial NCT05206981: Device Global Registry for the IlluminOss Bone Stabilization System
Official title: IlluminOss Device Global Registry - A Prospective, Post-Market, Multi-Center Evaluation of the Clinical Outcomes of the IlluminOss Device
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Traumatic Fracture
Pathological Fracture
Lead sponsor: IlluminOss Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-25
Enrollment: 300
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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. The device will be used in a manner consistent with the treating physician's regular clinical practice.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composite Safety Success Rate
timeFrame: 12 Months
Secondary outcomes:
measure: Complications/Adverse Events
timeFrame: 12 Months
measure: Successful Device Implantation
timeFrame: 12 Months
measure: Fracture Healing
timeFrame: 12 Months
measure: Disability & Return to Work Status
timeFrame: 12 Months
measure: Discharge Status
timeFrame: 12 Months
measure: Visual Analog Pain Score
timeFrame: 12 Months
measure: Veterans Rand 12 Item Health Survey
timeFrame: 12 Months
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function
timeFrame: 12 Months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Gulf Orthopedics
state: Alabama
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Denver
country: United States
facility: Presbyterian St Luke's Medical Ctr
state: Colorado
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Weston
country: United States
facility: Weston Outpatient Surgical Center
state: Florida
city: Fort Wayne
country: United States
facility: Parkview Health
state: Indiana
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Asheville
country: United States
facility: Mission Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Wakefield
country: United States
facility: Ortho Rhode Island
state: Rhode Island
city: Katy
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Cologne
country: Germany
facility: St Vinzenz Hospital
city: Minden
country: Germany
facility: Johannes Wesling Hospital Minden
city: Wuppertal
country: Germany
facility: Petrus Hospital
Study officials:
References: