Treatment of Unstable Trochanteric Fractures With the Proximal Femoral Nail - Antirotation Asia - A Prospective Multicenter Case Series

AO Clinical Investigation and Publishing Documentation1 site in 1 country245 target enrollmentNovember 2007

ConditionsTrochanteric Fractures

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Trochanteric Fractures
Sponsor: AO Clinical Investigation and Publishing Documentation
Enrollment: 245
Locations: 1
Primary Endpoint: Bone/fracture- or implant/surgery-related fracture fixation complication events
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2007

End Date

March 2012

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AO Clinical Investigation and Publishing Documentation

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Bone/fracture- or implant/surgery-related fracture fixation complication events

Time Frame: 6 and 12 weeks, 6 and 12 months

Secondary Outcomes

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)