Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IlluminOss Device | Device | Patients may enroll in the registry if they have been implanted (retrospective) or will be implanted (prospective) with the IlluminOss device. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Safety Success Rate | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Complications/Adverse Events | 12 Months | |
| Successful Device Implantation | 12 Months | |
| Fracture Healing |
Not provided
Inclusion Criteria:
Exclusion Criteria:
United States (U.S.)
This product is contraindicated in U.S. patients who have:
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.
Vascular insufficiency, muscular atrophy, or neuro-muscular disease.
Not provided
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Holt, PhD | Contact | 401-714-0008 | lholt@illuminoss.com | |
| Caitlin Smith, MPH | Contact | 401-714-0008 | csmith@illuminoss.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gulf Orthopedics | Completed | Mobile | Alabama | 36604 | United States | |
| Cedars-Sinai Medical Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 12 Months |
| Disability & Return to Work Status | 12 Months |
| Discharge Status | 12 Months |
| Visual Analog Pain Score | 12 Months |
| Veterans Rand 12 Item Health Survey | 12 Months |
| Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function | 12 Months |
| Recruiting |
| Los Angeles |
| California |
| 90048 |
| United States |
|
| Presbyterian St Luke's Medical Ctr | Recruiting | Denver | Colorado | 80218 | United States |
|
| University of Miami Hospital | Recruiting | Miami | Florida | 33136 | United States |
|
| Weston Outpatient Surgical Center | Recruiting | Weston | Florida | 33326 | United States |
|
| Parkview Health | Withdrawn | Fort Wayne | Indiana | 46845 | United States |
| Jacobi Medical Center | Recruiting | The Bronx | New York | 10461 | United States |
|
| Mission Hospital | Withdrawn | Asheville | North Carolina | 28801 | United States |
| Wake Forest Baptist Health | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
|
| Temple University Hospital | Recruiting | Philadelphia | Pennsylvania | 19140 | United States |
|
| University of Pittsburgh Medical Center | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
|
| Ortho Rhode Island | Recruiting | Wakefield | Rhode Island | 02879 | United States |
|
| Memorial Hermann Hospital | Recruiting | Katy | Texas | 77494 | United States |
|
| St Vinzenz Hospital | Withdrawn | Cologne | Germany |
| Johannes Wesling Hospital Minden | Completed | Minden | Germany |
| Petrus Hospital | Completed | Wuppertal | Germany |
| ID | Term |
|---|---|
| D005598 | Fractures, Spontaneous |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
Not provided
Not provided