Treatment of Unstable Trochanteric Fractures With the Proximal Femoral Nail - Antirotation (PFNA)-Asia

AO Clinical Investigation and Publishing Documentation

Status: Completed

Conditions: Trochanteric Fractures

Treatments: Device: PFNA-Asia

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00873548

PFNA_Asia

Details and patient eligibility

About

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.

Full 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 neck angles and a more anterior bowing of the shaft than white Americans. This was one of the reasons for the development of a new PFNA Asia with adapted sizes and geometry. No controlled clinical data are available whether the rate of mismatch and mismatch-related complications could be reduced.

Enrollment: 245 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

245 participants in 1 patient group

PFNA_Asia treated

Treatment:

Device: PFNA-Asia