Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation

AO Clinical Investigation and Publishing Documentation

Status and phase

Completed

Phase 4

Conditions

Hip Fractures

Closed Fracture of Hip

Treatments

Device: PFNA (Synthes)

Device: PFNA Augmentation (Synthes)

Study type

Interventional

Funder types

Other

Identifiers

NCT01473082

PFNA augmented

Details and patient eligibility

About

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.

Full description

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.

Enrollment

251 patients

Sex

All

Ages

75+ years old

Volunteers

No Healthy Volunteers

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