Clinical trial NCT01473082: Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation
Official title: Comparison of Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation for the Treatment of Closed Unstable Trochanteric Fractures - A Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hip Fractures
Closed Fracture of Hip
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2011-11-17
Enrollment: 251
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mobility measured with the "timed up & go"-test during hospital stay.
timeFrame: 5 to 7 days postoperative
Secondary outcomes:
measure: Description of surgical details as surgery time and fluoroscopy time, and of augmentation details (PFNA Augmentation group only).
timeFrame: Intraoperative
measure: Pain
timeFrame: one year
measure: Duration of hospital stay
timeFrame: one year
measure: Walking ability
timeFrame: one year
measure: Return to pre-fracture residential status
timeFrame: one year
measure: Timed up & go-test at follow-ups
timeFrame: one year
measure: Quality of life
timeFrame: one year
measure: Local adverse events and revision rate
timeFrame: one year
measure: Systemic adverse events
timeFrame: one year
measure: Implant migration
timeFrame: one year
measure: Mortality
timeFrame: one year
measure: Fracture risk prior to injury
timeFrame: 1 week prior to operation
measure: Functional independence
timeFrame: 1 week prior to operation
measure: Comorbidity
timeFrame: 1 week prior to operation
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
city: Leuven
country: Belgium
facility: KUL Univ. Ziekenhuizen Leuven
city: Tübingen
country: Germany
facility: BGU Tübingen
city: Ulm
country: Germany
facility: University of Ulm
city: Weimar
country: Germany
facility: Sophien und Hufeland Klinikum GmbH
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
city: Tønsberg
country: Norway
facility: Sykehuset i Vestfold HF Tønsberg
city: Lucerne
country: Switzerland
facility: Cantonal Hospital Lucerne
city: Zürich
country: Switzerland
facility: City Hospital Waid
Study officials:
affiliation: AO Clinical Investigation and Documentation, Davos, Switzerland
name: Andreas Faeh
role: STUDY_DIRECTOR
affiliation: Medical University of Innsbruck, Austria
name: Christian Kammerlander, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kammerlander C, Hem ES, Klopfer T, Gebhard F, Sermon A, Dietrich M, Bach O, Weil Y, Babst R, Blauth M. Cement augmentation of the Proximal Femoral Nail Antirotation (PFNA) - A multicentre randomized controlled trial. Injury. 2018 Aug;49(8):1436-1444. doi: 10.1016/j.injury.2018.04.022. Epub 2018 Apr 22.