n.v.t.
Source
Brief title
Condition
- Fractures
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
n.v.t.
Secondary outcome
n.v.t.
Background summary
n.v.t.
Study objective
n.v.t.
Study design
n.v.t.
Study burden and risks
n.v.t.
Waterman Avenue 993
East Province, RI 02914
US
Waterman Avenue 993
East Province, RI 02914
US
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL41632.072.12 |