Treatment with Fixion Proximal Femur Nailing System will give less complications than treatment with Gamma 3 Nail in unstable proximal femur fractures.
ID
Bron
Verkorte titel
Aandoening
Fixion Nail in proximal femur fractures
(NLD: Fixion nail in proximale femur fracturen).
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Major and minor implant related;<br>
2. complication rate;<br>
Achtergrond van het onderzoek
The Fixion Proximal Femur Nailing System
is a relatively new intramedullar nail. The background of the study is to investigate it's use in (un)stable proximal femur fractures. The hypothesis is that there is a reduced infection risk, a minimized fluoroscopy exposure, reduced mortality and a reduced procedure time, in comparison with the Gamma 3 Nail.
It's a single blinded randomized clinical evaluation of the treatment and results of intramedullary nailing for (un)stable proximal femur fractures. Patients will be randomized for the Gamma 3 nail group or the Fixion PF Nailing System.
The study population will be human volunteers with a minimal age of 18 years old with a (un)stable proximal femur fracture.
The risks associated with participation are not different from the regular therapy and follow-up of a pertrochanteric femur fracture.
Doel van het onderzoek
Treatment with Fixion Proximal Femur Nailing System will give less complications than treatment with Gamma 3 Nail in unstable proximal femur fractures.
Onderzoeksopzet
0, 3, 6, 12, 24, 48 weeks postoperative
Onderzoeksproduct en/of interventie
Intervention: Fixion Proximal Femur Nailing System.
Control: Gamma 3 nail.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Proximal femur fractures with AO-classification 31 A1.1 - A3.3;
2. >18 years;
3. admitted to hospital.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Primairy bone disease:
a. fibrous dysplasia;
b. Gaucher's disease;
c. osteogenesis imperfecta;
d. osteomalcia;
e. osteomyelitis;
f. Pagets disease;
g. renal oseodystrophy;
h. periprothetic fractures;
2. life expectency <1 year;
3. patient can't speak Dutch.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1098 |
| NTR-old | NTR1133 |
| Ander register | METC Atrium-Maasland : nog niet bekend, wordt 30 november ingediend |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |