The primary objective of the study is to investigate the number of complications (infection, nonunion, nerve damage). Secondary objectives will be procedure time, peroperative fluoroscopic , hospitalisation time and resumption of full activities.
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of the study is to investigate the number of
complications (infection, nonunion, nerve damage).
Secondary outcome
Secondary objectives will be procedure time, peroperative fluoroscopic ,
hospitalisation time and resumption of full activities.
Background summary
The Fixion® IM Humeral nail is a relatively new intramedullary nail, that isn*t
much investigated. The background of the study is to investigate it*s use in
fractures of the humeral shaft. The hypothesis is that there is a reduced
infection risk, a minimized fluoroscopy exposure and a reduced procedure time,
in comparison with the T2* Humeral nail.
Study objective
The primary objective of the study is to investigate the number of
complications (infection, nonunion, nerve damage). Secondary objectives will be
procedure time, peroperative fluoroscopic , hospitalisation time and resumption
of full activities.
Study design
The study is a multicenter prospective single blinded randomized clinical
evaluation of the treatment and results of intramedullary nailing for humeral
shaft fractures. Patients will be randomized for the T2* Humeral nail group or
the Fixion ® IM Humeral nail group
Intervention
T2* Humeral nail or the Fixion ® IM Humeral nail
Study burden and risks
The risks associated with participation are no different from the regular
therapy and follow-up of a humeral shaft fracture.
Henri Dunantstraat 5
6401 CX Heerlen
Nederland
Henri Dunantstraat 5
6401 CX Heerlen
Nederland
Listed location countries
Age
Inclusion criteria
minimal age of 18 years or older with a humerus diaphyseal fracture
Exclusion criteria
- Gustilo and Anderson classification III-C
- Primary bone disease
- Postoperative treatment in an hospital not participating in the study
Design
Recruitment
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 | NL17500.096.07 |