Proximal Femoral Nail Antirotation™ (PFNA) Versus Gamma Nail 3™ (Gamma3) for Intramedullary Nailing of Unstable Trochanteric Fractures
Launched by AO CLINICAL INVESTIGATION AND PUBLISHING DOCUMENTATION · Aug 15, 2008
Trial Information
Current as of June 03, 2025
Completed
Keywords
ClinConnect Summary
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 ra...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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
About Ao Clinical Investigation And Publishing Documentation
AO Clinical Investigation and Publishing Documentation is a leading organization dedicated to advancing medical research through the rigorous evaluation of clinical trials. Specializing in the design, implementation, and dissemination of clinical studies, AO focuses on enhancing patient outcomes and contributing to the body of scientific knowledge. With a commitment to ethical standards and regulatory compliance, the organization collaborates with healthcare professionals and institutions to ensure high-quality data collection and analysis. Their expertise in publishing ensures that findings are effectively communicated to the medical community, fostering innovation and informed decision-making in patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Madrid, , Spain
Madrid, , Spain
Santander, Cantabria, Spain
Barcelona, Cataluña, Spain
Murcia, , Spain
San Sebastián, , Spain
Patients applied
Trial Officials
Beate P. Hanson, MD
Study Director
AO Clinical Investigation and Documentation, Davos, Switzerland
Javier Vaquero Martin, MD
Principal Investigator
Hospital Gregorio Marañon, Madrid, Spain
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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