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Intramedullary Nailing of proximal femur fractures: Gamma 3 Nail versus Fixion Proximal Femur Nailing System.


- candidate number2876
- NTR NumberNTR1133
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-nov-2007
- Secondary IDsnog niet bekend, wordt 30 november ingediend METC Atrium-Maasland
- Public TitleIntramedullary Nailing of proximal femur fractures: Gamma 3 Nail versus Fixion Proximal Femur Nailing System.
- Scientific TitleIntramedullary Nailing of proximal femur fractures: Gamma 3 Nail versus Fixion Proximal Femur Nailing System.
- ACRONYMGammafix
- hypothesisTreatment with Fixion Proximal Femur Nailing System will give less complications than treatment with Gamma 3 Nail in unstable proximal femur fractures.
- Healt Condition(s) or Problem(s) studiedFemoral fractures
- Inclusion criteria1. Proximal femur fractures with AO-classification 31 A1.1 - A3.3;
2. >18 years;
3. admitted to hospital.
- Exclusion criteria1. 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.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2008
- planned closingdate30-dec-2009
- Target number of participants244
- InterventionsIntervention: Fixion Proximal Femur Nailing System.
Control: Gamma 3 nail.
- Primary outcome1. Major and minor implant related;
2. complication rate;
- Secondary outcome1. Procedure time;
2. preoperative fluoroscopic rime;
3. number of infections;
4. resumption of full activities;
5. mortality.
- Timepoints0, 3, 6, 12, 24, 48 weeks postoperative
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES A.M. Bek
- CONTACT for SCIENTIFIC QUERIES A.M. Bek
- Sponsor/Initiator Atrium Medisch Centrum Parkstad
- Funding
(Source(s) of Monetary or Material Support)
Atrium Medisch Centrum Parkstad
- PublicationsN/A
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD12-nov-2007 - 3-apr-2008


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