bone fracture fracture
Conditions
Interventions
None listed
Sponsors
IlluminOss Medical, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: All patients who received the device under compassionate use or palliative care conditions will be asked to participate in the registry (retrospective). In addition, patients who have broken a phalange, metacarpal, distal radius, radius, ulna, clavicle, olecranon and/or fibula and will be treated with an IlluminOss device will be asked to participate in the registry (prospective).
Exclusion criteria
Exclusion criteria: Contra-indications: 1.Skeletally immature men and women 2.Patients with distant foci of infections with may spread to the implant site. 3.Patients allergic to implant materials or dental glue 4. An intramedullary canal smaller than 3,5 mm (diameter) at site of the fracture. 5. Uncooperative patient or patient with neurological disorder, incapagle of following directions. 6. Patients with concomitant metabolic disorders which may impair bone formation. 7. Patients with osteomalacia 8. Patients with distant foci of infections with may spread to the implant site. 9. Patients with marked bone loss or bone resorption. 10. Vaccular insufficiency, muscleatrophy or neuromuscularcular diseases. 11. Patients with open fractures with severe contamination 12.Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable. 13.Patients where the delivery sheath is unable to pass fracture after adequate reduction and alignment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| n.v.t. | — |
Secondary
| Measure | Time frame |
|---|---|
| n.v.t. | — |
Countries
Netherlands
Outcome results
None listed