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

Study Overview
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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).

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.

Official Title
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Proximal Femoral Nail Antirotation™ (PFNA) Versus Gamma Nail 3™ (Gamma3) for Intramedullary Nailing of Unstable Trochanteric Fractures - a Multicenter Randomized Controlled Trial

Conditions
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Unstable Trochanteric Fractures

Intervention / Treatment
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* Device: Proximal Femoral Nail AntirotationTM (PFNA)
* Device: Gamma Nail 3TM (Gamma3)


Participation Criteria
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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 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 Inability to walk independently prior to injury event (use of one stick is allowed. Not meeting inclusion criteria are bedridden, wheel-chair ridden and walker dependent subjects) Neurological and psychiatric disorders that would preclude reliable assessment (eg,, Parkinson disease, Multiple sclerosis, severe depression) Rheumatoid arthritis

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Proximal Femoral Nail AntirotationTM (PFNA) | Device: Proximal Femoral Nail AntirotationTM (PFNA)<br>* intramedullary nailing<br>|
| Other: 2<br>Gamma Nail 3TM (Gamma3) | Device: Gamma Nail 3TM (Gamma3)<br>* intramedullary nailing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any fracture fixation complication. |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone union/fusion as evaluated by CT-scanning, health-related quality of life, disease-specific functional scoring, activities of daily living, mortality, radiological parameters, surgery details and surgeons' evaluation of handling and effectiveness. |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Femoral fractures [MeSH], hip fractures [MeSH], trochanteric fractures (femoral neck fractures [MeSH]), intramedullary nailing (fracture fixation, intramedullary [MeSH]), complex femoral fractures, femoral nail, surgical treatment (surgical procedures, operative [MeSH]), complications