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

Completed

• Conditions: Trochanteric Fractures
• Interventions: Device: PFNA-Asia

• Registration Number: NCT00873548
• Lead Sponsor: AO Clinical Investigation and Publishing Documentation

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 (PFNA Asia) for the treatment of unstable trochanteric fractures.

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 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.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2009-03-31
• Study First Submitted QC: 2009-03-31
• Study First Posted: 2009-04-01
• Primary Completion: 2011-12
• Study Completion: 2012-03
• Status Verified: 2013-01
• Last Update Submitted: 2021-07-21
• Last Update Posted: 2021-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PFNA_Asia treated	PFNA-Asia	-

Primary Outcome Measures

Name	Time	Method
Bone/fracture- or implant/surgery-related fracture fixation complication events	6 and 12 weeks, 6 and 12 months

Secondary Outcome Measures

Name	Time	Method
Mismatch	Perioperatively
Soft tissue/wound -related or general complications	6 and 12 weeks, 6 and 12 months
Length of hospital stay	till 12 weeks after surgery
Walking ability (Parker mobility score)	Baseline, 6 and 12 months
Range of motion (ROM)	6 and 12 weeks, 6 and 12 months
Capacity to return to pre-residential status	12 weeks
Bone consolidation and anatomical restoration	6 and 12 weeks, 6 and 12 months
Health-related quality of life assessed by the generic SF-36-instrument and EQ-5D	Baseline, 6 and 12 months
Mortality	6 and 12 weeks, 6 and 12 months
Surgery details and postoperative treatment	till 12 weeks after surgery

Trial Locations

Locations (1)

Toyama Municipal Hospital; 🇯🇵 Toyama, Japan