Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation

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

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.

Study Overview

• Status: Completed
• Conditions: Hip Fractures; Closed Fracture of Hip
• Intervention / Treatment: Device: PFNA (Synthes); Device: PFNA Augmentation (Synthes)

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.

• Study Type: Interventional
• Enrollment (Actual): 251
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Medical University of Innsbruck
• Belgium
  • Leuven, Belgium, 3000
    • KUL Univ. Ziekenhuizen Leuven
• Germany
  • Tübingen, Germany, 72076
    • BGU Tübingen
  • Ulm, Germany, 89075
    • University of Ulm
  • Weimar, Germany, 99425
    • Sophien und Hufeland Klinikum GmbH
• Israel
  • Jerusalem, Israel, 91120
    • Hadassah Medical Organization
• Norway
  • Tønsberg, Norway, 3103
    • Sykehuset i Vestfold HF Tønsberg
• Switzerland
  • Lucerne, Switzerland, 6000
    • Cantonal Hospital Lucerne
  • Zürich, Switzerland, 8037
    • City Hospital Waid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PFNA; Proximal Femoral Nail Antirotation (PFNA Synthes)	Device: PFNA (Synthes); Proximal Femoral Nail Antirotation (PFNA); Other Names: PFNA length 240 mm; PFNA small length 200 mm; PFNA xs length 170 mm; PFNA long lengths 300-420 mm
Active Comparator: PFNA Augmentation; Proximal Femoral Nail Antirotation PFNA Augmentation (Synthes) with Traumacem V+ Synthes	Device: PFNA Augmentation (Synthes); Proximal Femoral Nail Antirotation (PFNA) Augmentation (with Traumacem V+); Other Names: PFNA Augmentation (Synthes) length 240 mm; PFNA Augmentation (Synthes) small length 200 mm; PFNA Augmentation (Synthes) xs length 170 mm; PFNA Augmentation (Synthes) long lengths 300-420 mm

What is the study measuring?

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
Mortality		one year
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
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

Collaborators and Investigators

• Sponsor: AO Clinical Investigation and Publishing Documentation
• Investigators: Study Director: Andreas Faeh, AO Clinical Investigation and Documentation, Davos, Switzerland; Principal Investigator: Christian Kammerlander, MD, Medical University of Innsbruck, Austria

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: November 10, 2011
• First Submitted That Met QC Criteria: November 14, 2011
• First Posted (Estimate): November 17, 2011

Study Record Updates

• Last Update Posted (Actual): August 13, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Fractures, Closed
• Other Study ID Numbers: PFNA augmented