Proximal Femoral Nail Antirotation™ (PFNA) Versus Gamma Nail 3™ (Gamma3) for Intramedullary Nailing of Unstable Trochanteric Fractures

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

Clinical Phase

PHASE4

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2010-09-30

Brief Summary

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The purpose of this study is to compare rates of any fracture fixation complication and revision rates after intramedullary fixation of unstable trochanteric fractures between the Proximal Femoral Nail Antirotation™ (PFNA)(Investigational Group) and Gamma Nail 3™ (Gamma3) (Control Group).

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Detailed Description

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Intramedullary nailing of unstable per- and subtrochanteric femoral fractures is a standard procedure in trauma and orthopaedic surgery. Unstable fractures treated with intramedullary nailing carry the risk of fracture fixation complications. The PFNA (Synthes) has evolved from the original PFN design, featuring a novel antirotation screw. Apart from the prevention of excess rotational forces, this supporting element may enhance the overall stability of the construct, thus potentially reducing fracture fixation complications. Empirical information about the fracture fixation complication rates of the PFNA device is not available. The primary objective of this study is to compare the 1-year fracture fixation rates between the PFNA and Gamma Nail 3™ (Stryker). Secondary objectives of the study are to compare differences in functional outcomes, quality of life outcomes, safety, radiological outcomes, handling and perceived effectiveness between the devices.

Conditions

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Unstable Trochanteric Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Proximal Femoral Nail AntirotationTM (PFNA)

Group Type ACTIVE_COMPARATOR

Proximal Femoral Nail AntirotationTM (PFNA)

Intervention Type DEVICE

intramedullary nailing

2

Gamma Nail 3TM (Gamma3)

Group Type OTHER

Gamma Nail 3TM (Gamma3)

Intervention Type DEVICE

intramedullary nailing

Interventions

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Proximal Femoral Nail AntirotationTM (PFNA)

intramedullary nailing

Intervention Type DEVICE

Gamma Nail 3TM (Gamma3)

intramedullary nailing

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age 55 years and more
* Patients with isolated, unstable, closed or type 1 open trochanteric fractures, classified as AO 31-A2 or AO 31-A3
* Definitive primary fracture treatment with PFNA or Gamma3 (defined inTable 1) within three days after the index event
* Signed written informed consent (by the subjects or legal guardian) and agreement to attend the planned follow-ups

* Neurological and psychiatric disorders that would preclude reliable assessment (eg,, Parkinson disease, Multiple sclerosis, severe depression)
* Rheumatoid arthritis

Exclusion Criteria

* Pathologic fracture of any other cause than osteoporosis
* Patients or legal guardian refusing to sign the informed consent form
* Multiple trauma
* Type 2 and 3 open fractures
* Drug or alcohol abuse
* Wound and/or bone healing disorders of any other cause than diabetes mellitus or smoking
* Active malignancy
* Expected life expectancy ≤ 3 months

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes