Treatment of Unstable Trochanteric Fractures With the Proximal Femoral Nail

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

245 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2012-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Trochanteric Fractures

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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PFNA_Asia treated

PFNA-Asia

Intervention Type DEVICE

The operation is performed under regional or general anesthesia and involves the following main steps:

1. Positioning of the patient
2. Definition of the CCD-angle
3. Fracture reduction
4. Determination of the nail diameter
5. Incision
6. Insertion of the device

Interventions

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PFNA-Asia

The operation is performed under regional or general anesthesia and involves the following main steps:

1. Positioning of the patient
2. Definition of the CCD-angle
3. Fracture reduction
4. Determination of the nail diameter
5. Incision
6. Insertion of the device

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No