Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation

Launched by AO CLINICAL INVESTIGATION AND PUBLISHING DOCUMENTATION · Nov 14, 2011

Keywords

ClinConnect Summary

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...

Gender

ALL

Eligibility criteria

• 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

Trial Officials