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Hip Fractures
+1

Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation

Sponsored by AO Clinical Investigation and Publishing Documentation

About this trial

Last updated 5 years ago

Study ID

PFNA augmented

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

18-75 Years
75+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 10 years ago

What is this trial 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.

What are the participation requirements?

Yes

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

No

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