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.
Who can participate
Age range75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, hyd…
What they're measuring
1
Mobility measured with the "timed up & go"-test during hospital stay.
Timeframe: 5 to 7 days postoperative
Trial details
NCT IDNCT01473082
SponsorAO Clinical Investigation and Publishing Documentation