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

AO Clinical Investigation and Publishing Documentation440 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

440

Conditions

Unstable Trochanteric Fractures

Interventions

Proximal Femoral Nail AntirotationTM (PFNA)DEVICE

intramedullary nailing

Gamma Nail 3TM (Gamma3)DEVICE

intramedullary nailing

Eligibility

Sex: ALLMin age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (6)

Hospital Universitario "Marqués de Valdecilla"

Santander, Cantabria, Spain

Hospital Clinic

Barcelona, Catalonia, Spain

Hospital Gregorio Marañon

Madrid, Madrid, Spain

Hospital Puerta de Hierro

Madrid, Madrid, Spain

Outcomes

Primary Outcomes

Any fracture fixation complication.

Time frame: One year

Secondary Outcomes

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.

Time frame: One year

Data from ClinicalTrials.gov

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