Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation

Comparison of Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation for the Treatment of Closed Unstable Trochanteric Fractures - A Randomized-controlled Trial

The purpose of this study is to evaluate whether patients with trochanteric fractures being treated with a Proximal Femoral Nail Antirotation (PFNA) and augmentation can better be mobilized than patients without augmentation.

To avoid the pain-causing relative movement between implant and bone, surgical techniques and devices allowing augmentation of the femoral head have recently been developed. Biomechanical studies showed that augmentation leads to a better axial stability and pull-out strength. In clinical practice, this might facilitate early mobilization and full weight-bearing with less pain. The purpose of this study is therefore to evaluate whether patients with trochanteric fractures being treated with a PFNA and augmentation can better be mobilized than patients without augmentation. In particular, it will be measured whether patients with a PFNA Augmentation can walk faster than the non-augmented patients, measured with the Timed up and Go test.

Inclusion Criteria:

• Age 75 years and older
• Closed unstable trochanteric fracture: AO 31 - A2 and A3
• Low energy trauma (e.g.fall from standing height)
• Definitive fracture fixation within 72 hrs. after admission
• Indication for PFNA fixation (with or without augmentation)
• Ability to walk independently (walking aids are allowed) prior to injury
• Signed written informed consent and agreement to attend the planned FUs
• Able to understand and read country national language at an elementary level

Exclusion Criteria:

• Pathologic fracture
• Polytrauma
• Any additional fracture
• Open fracture
• Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
• Active malignancy defined as history of invasive malignancy, except if the patient has received treatment and displayed no clinical signs and symptoms for at least five years
• ASA class V and VI
• Any implant at the same hip
• Hemiplegia
• Patients with legal guardian
• Patients who have participated in any other device or drug related clinical trial that could influence the results of the present study within the previous month
• Fractures and injuries opening into the articulation and vascular structure
• Infection
• Patients with clotting disorders
• Patients with severe cardiac and / or pulmonary insufficiency
• Patients with known hypersensitivity or allergy to any of the components of Traumacem V+ cement (Polymethyl methacrylate / acrylate, zirconium dioxide, hydroxyapatite,benzoyl peroxide, methyl methacrylate,hydroquinone, N,N-dimethyl-p-toluidine)
• Perforation of the femoral head into the joint with the guide wire used for the PFNA blade
• Risk of potential leakage into the joint identified by using contrast fluid (PFNA Augmentation group only)
• Intraoperative decision to use implants other than PFNA