Status:
COMPLETED
Proximal Femoral Nail Antirotation™ (PFNA) Versus Gamma Nail 3™ (Gamma3) for Intramedullary Nailing of Unstable Trochanteric Fractures
Lead Sponsor:
AO Clinical Investigation and Publishing Documentation
Collaborating Sponsors:
Synthes Inc.
Conditions:
Unstable Trochanteric Fractures
Eligibility:
All Genders
55+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare rates of any fracture fixation complication and revision rates after intramedullary fixation of unstable trochanteric fractures between the Proximal Femoral Nai...
Detailed Description
Intramedullary nailing of unstable per- and subtrochanteric femoral fractures is a standard procedure in trauma and orthopaedic surgery. Unstable fractures treated with intramedullary nailing carry th...
Eligibility Criteria
Inclusion
- Age 55 years and more
- Patients with isolated, unstable, closed or type 1 open trochanteric fractures, classified as AO 31-A2 or AO 31-A3
- Definitive primary fracture treatment with PFNA or Gamma3 (defined inTable 1) within three days after the index event
- Signed written informed consent (by the subjects or legal guardian) and agreement to attend the planned follow-ups
Exclusion
- Pathologic fracture of any other cause than osteoporosis
- Patients or legal guardian refusing to sign the informed consent form
- Multiple trauma
- Type 2 and 3 open fractures
- Drug or alcohol abuse
- Wound and/or bone healing disorders of any other cause than diabetes mellitus or smoking
- Active malignancy
- Expected life expectancy ≤ 3 months
- Inability to walk independently prior to injury event (use of one stick is allowed. Not meeting inclusion criteria are bedridden, wheel-chair ridden and walker dependent subjects)
- Neurological and psychiatric disorders that would preclude reliable assessment (eg,, Parkinson disease, Multiple sclerosis, severe depression)
- Rheumatoid arthritis
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT00736684
Start Date
November 1 2007
End Date
September 1 2010
Last Update
February 11 2011
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitario "Marqués de Valdecilla"
Santander, Cantabria, Spain, 39008
2
Hospital Clinic
Barcelona, Catalonia, Spain, 08036
3
Hospital Gregorio Marañon
Madrid, Madrid, Spain, 28007
4
Hospital Puerta de Hierro
Madrid, Madrid, Spain, 28035