Status:
COMPLETED
Treatment of Unstable Trochanteric Fractures With the Proximal Femoral Nail - Antirotation (PFNA)-Asia
Lead Sponsor:
AO Clinical Investigation and Publishing Documentation
Collaborating Sponsors:
Synthes Inc.
Conditions:
Trochanteric Fractures
Eligibility:
All Genders
65+ years
Brief 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 (P...
Detailed Description
From several studies, e.g. on hip prostheses, it is known that the Asian population has other geometric proportions than Caucasians, e.g. Japanese woman have shorter femoral necks, smaller femoral nec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT00873548
Start Date
November 1 2007
End Date
March 1 2012
Last Update
July 22 2021
Active Locations (1)
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1
Toyama Municipal Hospital
Toyama, Japan, 939-8511