Proximal Femoral Nail Antirotation™ (PFNA) Versus Gamma Nail 3™ (Gamma3) for Intramedullary Naili… (NCT00736684) | Clinical Trial Compass
CompletedPhase 4
Proximal Femoral Nail Antirotation™ (PFNA) Versus Gamma Nail 3™ (Gamma3) for Intramedullary Nailing of Unstable Trochanteric Fractures
Spain440 participantsStarted 2007-11
Plain-language 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).
Who can participate
Age range55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Any fracture fixation complication.
Timeframe: One year
Trial details
NCT IDNCT00736684
SponsorAO Clinical Investigation and Publishing Documentation