The objective is to investigate the excess value of the Fixion Proximal Femur Nailing System in comparison with the Gamma 3 Nail in patients with an unstable pertrochanteric femur fracture.
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.
Secondary outcome
secondary objectives will be procedure time, peroperative fluoroscopic time,
number of infections, hospitalisation time and resumption of full activities.
Background summary
The Fixion TM PF Nailing System is a relatively new intramedullary nail, that
is not investigated much. This nail is expandable and self-locking, so the
inital diameter to introduce the nail is smal. No interlocking screws are
needed. At the Atrium Medical centre unstable pertrochanteric femur fractures
are treated with the Gamma 3 Nail. We want to use the FixionTM PF Nailing
System in pertrochanteric femur fractures. The hypothesis is that there is a
reduced infection risk, a minimized fluoroscopy exposure and a reduced
procedure time, in comparison with the Gamma 3 Nail.
Study objective
The objective is to investigate the excess value of the Fixion Proximal Femur
Nailing System in comparison with the Gamma 3 Nail in patients with an unstable
pertrochanteric femur fracture.
Study design
The study is a single centre, prospective, randomized trial
Intervention
Gamma 3 Nail versus Fixion Proximal Femur Nailing System
Study burden and risks
The risks associated with participation are no different from the regular
therapy and follow-up of an unstable pertrochanteric femur fracture.
postbus 4446
6401 CX Heerlen
Nederland
postbus 4446
6401 CX Heerlen
Nederland
Listed location countries
Age
Inclusion criteria
proximal femur fractures with AO-classification 31 A1.1 - A3.3;> 18 years;admitted to hospital
Exclusion criteria
primairy bone disease
- fibrous dysplasia
- Gaucher's disease
- osteogenesis imperfecta
- osteomalcia
- osteomyelitis
- Pagets disease
- renal oseodystrophy;life expectency < 1 year;patient can't speak Dutch
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 | NL20680.096.07 |