Proximal Femoral Nail Antirotation™ (PFNA) Versus Gamma Nail 3™ (Gamma3) for Intramedullary Nailing of Unstable Trochanteric Fractures
- Conditions
- Unstable Trochanteric Fractures
- Interventions
- Device: Gamma Nail 3TM (Gamma3)Device: Proximal Femoral Nail AntirotationTM (PFNA)
- Registration Number
- NCT00736684
- Lead Sponsor
- AO Clinical Investigation and Publishing Documentation
- 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 Nail Antirotation™ (PFNA)(Investigational Group) and Gamma Nail 3™ (Gamma3) (Control Group).
- 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 the risk of fracture fixation complications. The PFNA (Synthes) has evolved from the original PFN design, featuring a novel antirotation screw. Apart from the prevention of excess rotational forces, this supporting element may enhance the overall stability of the construct, thus potentially reducing fracture fixation complications. Empirical information about the fracture fixation complication rates of the PFNA device is not available. The primary objective of this study is to compare the 1-year fracture fixation rates between the PFNA and Gamma Nail 3™ (Stryker). Secondary objectives of the study are to compare differences in functional outcomes, quality of life outcomes, safety, radiological outcomes, handling and perceived effectiveness between the devices.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 440
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Gamma Nail 3TM (Gamma3) Gamma Nail 3TM (Gamma3) 1 Proximal Femoral Nail AntirotationTM (PFNA) Proximal Femoral Nail AntirotationTM (PFNA)
- Primary Outcome Measures
Name Time Method Any fracture fixation complication. One year
- Secondary Outcome Measures
Name Time Method Bone union/fusion as evaluated by CT-scanning, health-related quality of life, disease-specific functional scoring, activities of daily living, mortality, radiological parameters, surgery details and surgeons' evaluation of handling and effectiveness. One year
Trial Locations
- Locations (6)
Hospital Universitario "Marqués de Valdecilla"
🇪🇸Santander, Cantabria, Spain
Hospital Gregorio Marañon
🇪🇸Madrid, Spain
Hospital Puerta de Hierro
🇪🇸Madrid, Spain
Hospital Clinic
🇪🇸Barcelona, Cataluña, Spain
H.U. Virgen de la Arrixaca
🇪🇸Murcia, Spain
Hospital Donostia
🇪🇸San Sebastián, Spain