Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation for the Treatment of Closed Unstable Trochanteric Fractures - A Randomized-controlled Trial

Conditions
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Hip Fractures, Closed Fracture of Hip

Intervention / Treatment
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* Device: PFNA Augmentation (Synthes)
* Device: PFNA (Synthes)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PFNA<br>Proximal Femoral Nail Antirotation (PFNA Synthes) | Device: PFNA (Synthes)<br>* Proximal Femoral Nail Antirotation (PFNA)<br>* Other names: PFNA long lengths 300-420 mm;|
| Active Comparator: PFNA Augmentation<br>Proximal Femoral Nail Antirotation PFNA Augmentation (Synthes) with Traumacem V+ Synthes | Device: PFNA Augmentation (Synthes)<br>* Proximal Femoral Nail Antirotation (PFNA) Augmentation (with Traumacem V+)<br>* Other names: PFNA Augmentation (Synthes) long lengths 300-420 mm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobility measured with the timed up & go-test during hospital stay. | 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. | 5 to 7 days postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of surgical details as surgery time and fluoroscopy time, and of augmentation details (PFNA Augmentation group only). |  | Intraoperative | 
| Pain | Pain, measured with the Numerical Rating Scale (NRS) and use of pain medication postoperative. | one year | 
| Duration of hospital stay |  | one year | 
| Walking ability | Parker Mobility Score | one year | 
| Return to pre-fracture residential status |  | one year | 
| Timed up & go-test at follow-ups | 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. | one year | 
| Quality of life | EuroQol-5D | one year | 
| Local adverse events and revision rate | Implant / surgery, bone / fracture, soft tissue of the musculoskeletal system, wound related adverse events | one year | 
| Systemic adverse events |  | one year | 
| Implant migration | Measured at the CT in a subgroup only | one year | 
| Mortality |  | one year | 
| Fracture risk prior to injury | Measured with the Fracture Risk Assessment Tool (FRAX) | 1 week prior to operation | 
| Functional independence | Measured with the Barthel Index | 1 week prior to operation | 
| Comorbidity | Charlson Comorbidiy Index | 1 week prior to operation |