Treatment of Unstable Trochanteric Fractures With the Proximal Femoral Nail - Antirotation (PFNA)… (NCT00873548) | Clinical Trial Compass
CompletedNot Applicable
Treatment of Unstable Trochanteric Fractures With the Proximal Femoral Nail - Antirotation (PFNA)-Asia
Japan245 participantsStarted 2007-11
Plain-language summary
The primary objective of this prospective multicenter study is to assess any fracture fixation complication and revision rates during the clinical use of the Proximal Femoral Nail Antirotation Asia (PFNA Asia) for the treatment of unstable trochanteric fractures.
Who can participate
Age range65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 65 years and older
* Patients with isolated, unstable, closed trochanteric fractures, classified as AO 31-A2 or AO 31-A3
* Definitive primary fracture treatment with PFNA Asia within 7 days sustaining the fracture (conversion from an external fixator to the PFNA Asia as an emergency procedure within the first week after the accident is allowed)
* Signed written informed consent (by the subjects or legal guardian) and agreement to attend the planned follow-ups
* Willing and able to comply with the post-operative management program
* Able to understand and read country national language at an elementary level
Exclusion Criteria:
* Pathologic fracture
* Patients or legal guardian refusing to sign the informed consent form
* Patients with previous implants on the fractured hip and femur
* Drug or alcohol abuse
* Active malignancy
* ASA class V and VI
* Patients who are bed-ridden or wheel-chair ridden prior to injury event
* Neurological disorders and psychiatric disorders that would preclude reliable assessment (e.g., Parkinson disease, Multiple sclerosis, severe depression)
* Patients who have participated in any other device or drug related clinical trial within the previous month
What they're measuring
1
Bone/fracture- or implant/surgery-related fracture fixation complication events
Timeframe: 6 and 12 weeks, 6 and 12 months
Trial details
NCT IDNCT00873548
SponsorAO Clinical Investigation and Publishing Documentation