Registry for the IlluminOss Bone Stabilization Device
IlluminOss Device Global Registry - A Prospective, Post-Market, Multi-Center Evaluation of the Clinical Outcomes of the IlluminOss Device
This study is collecting information on how well the IlluminOss Bone Stabilization Device works and keeps patients safe after surgery for broken bones.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | IlluminOss Medical, Inc. Industry-sponsored |
| Locations | 16 sites (Mobile, Alabama and 15 other locations) |
| Trial ID | NCT05206981 on ClinicalTrials.gov |
What this trial studies
This observational registry collects safety and performance data on the IlluminOss Device used for stabilizing and aligning traumatic and pathological fractures. Patient data will be gathered through questionnaires during standard care visits, including both prospective and retrospective data. Information collected will encompass demographics, surgical details, hospital discharge, adverse events, and patient-reported outcomes at various intervals post-operation. The aim is to evaluate the effectiveness and safety of the device in real-world clinical settings.
Who should consider this trial
Good fit: Ideal candidates include males or non-pregnant females over the age of 50 who are suitable for the IlluminOss device and willing to participate in follow-up evaluations.
Not a fit: Patients with active infections, allergies to implant materials, or unsuitable anatomical conditions for the device will not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the safety and effectiveness of the IlluminOss Device, potentially improving treatment outcomes for patients with fractures.
How similar studies have performed: While this registry approach is common, the specific use of the IlluminOss Device in this context is novel and has not been extensively tested in similar registries.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Mobile, Alabama and 15 other locations
- Gulf Orthopedics — Mobile, Alabama, United States (Completed)
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
- Presbyterian St Luke's Medical Ctr — Denver, Colorado, United States (Recruiting)
- University of Miami Hospital — Miami, Florida, United States (Recruiting)
- Weston Outpatient Surgical Center — Weston, Florida, United States (Recruiting)
- Parkview Health — Fort Wayne, Indiana, United States (Withdrawn)
- Jacobi Medical Center — The Bronx, New York, United States (Recruiting)
- Mission Hospital — Asheville, North Carolina, United States (Withdrawn)
- Wake Forest Baptist Health — Winston-Salem, North Carolina, United States (Recruiting)
- Temple University Hospital — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)
- Ortho Rhode Island — Wakefield, Rhode Island, United States (Recruiting)
- Memorial Hermann Hospital — Katy, Texas, United States (Recruiting)
- St Vinzenz Hospital — Cologne, Germany (Withdrawn)
- Johannes Wesling Hospital Minden — Minden, Germany (Completed)
- Petrus Hospital — Wuppertal, Germany (Completed)
Study contacts
- Study coordinator: Lisa Holt, PhD
- Email: lholt@illuminoss.com
- Phone: 401-714-0008
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.