Status:
COMPLETED
Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation
Lead Sponsor:
AO Clinical Investigation and Publishing Documentation
Conditions:
Hip Fractures
Closed Fracture of Hip
Eligibility:
All Genders
75+ years
Phase:
PHASE4
Brief Summary
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 patie...
Detailed 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 show...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
251 Patients enrolled
Trial Details
Trial ID
NCT01473082
Start Date
February 1 2012
End Date
January 1 2016
Last Update
August 13 2020
Active Locations (9)
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1
Medical University of Innsbruck
Innsbruck, Austria, 6020
2
KUL Univ. Ziekenhuizen Leuven
Leuven, Belgium, 3000
3
BGU Tübingen
Tübingen, Germany, 72076
4
University of Ulm
Ulm, Germany, 89075