Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation
- Conditions
- Hip FracturesClosed Fracture of Hip
- Interventions
- Device: PFNA (Synthes)Device: PFNA Augmentation (Synthes)
- Registration Number
- NCT01473082
- Lead Sponsor
- AO Clinical Investigation and Publishing Documentation
- 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 patients without augmentation.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 251
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PFNA PFNA (Synthes) Proximal Femoral Nail Antirotation (PFNA Synthes) PFNA Augmentation PFNA Augmentation (Synthes) Proximal Femoral Nail Antirotation PFNA Augmentation (Synthes) with Traumacem V+ Synthes
- Primary Outcome Measures
Name Time Method Mobility measured with the "timed up & go"-test during hospital stay. 5 to 7 days postoperative The TUG measures the time (in seconds) that it takes for an individual to rise from an armchair (chair seat height = 45 cm / 1.5 feet), walk 3 meters (= 10 feet) to a line drawn on the floor, turn around and return to the chair. The time is measured from a seated position (back against the backrest) with a stopwatch started on the command "ready - go" and stopped when the seat position is reached again. Patient-perceived pain and exertion will be assessed after the test.
- Secondary Outcome Measures
Name Time Method Local adverse events and revision rate one year Implant / surgery, bone / fracture, soft tissue of the musculoskeletal system, wound related adverse events
Functional independence 1 week prior to operation Measured with the Barthel Index
Pain one year Pain, measured with the Numerical Rating Scale (NRS) and use of pain medication postoperative.
Mortality one year Walking ability one year Parker Mobility Score
Systemic adverse events one year Timed up & go-test at follow-ups one year The TUG measures the time (in seconds) that it takes for an individual to rise from an armchair (chair seat height = 45 cm / 1.5 feet), walk 3 meters (= 10 feet) to a line drawn on the floor, turn around and return to the chair. The time is measured from a seated position (back against the backrest) with a stopwatch started on the command "ready - go" and stopped when the seat position is reached again.
Quality of life one year EuroQol-5D
Fracture risk prior to injury 1 week prior to operation Measured with the Fracture Risk Assessment Tool (FRAX)
Description of surgical details as surgery time and fluoroscopy time, and of augmentation details (PFNA Augmentation group only). Intraoperative Duration of hospital stay one year Return to pre-fracture residential status one year Implant migration one year Measured at the CT in a subgroup only
Comorbidity 1 week prior to operation Charlson Comorbidiy Index
Trial Locations
- Locations (9)
University of Ulm
🇩🇪Ulm, Germany
Hadassah Medical Organization
🇮🇱Jerusalem, Israel
Sophien und Hufeland Klinikum GmbH
🇩🇪Weimar, Germany
KUL Univ. Ziekenhuizen Leuven
🇧🇪Leuven, Belgium
BGU Tübingen
🇩🇪Tübingen, Germany
Sykehuset i Vestfold HF Tønsberg
🇳🇴Tønsberg, Norway
City Hospital Waid
🇨🇭Zürich, Switzerland
Medical University of Innsbruck
🇦🇹Innsbruck, Austria
Cantonal Hospital Lucerne
🇨🇭Lucerne, Switzerland