Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation

NCT ID: NCT01473082

Last Updated: 2020-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 251 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2016-01-31

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.

Conditions

Hip Fractures; Closed Fracture of Hip

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PFNA

Proximal Femoral Nail Antirotation (PFNA Synthes)

Group Type: ACTIVE_COMPARATOR

PFNA (Synthes)

Intervention Type: DEVICE

Proximal Femoral Nail Antirotation (PFNA)

PFNA Augmentation

Proximal Femoral Nail Antirotation PFNA Augmentation (Synthes) with Traumacem V+ Synthes

Group Type: ACTIVE_COMPARATOR

PFNA Augmentation (Synthes)

Intervention Type: DEVICE

Proximal Femoral Nail Antirotation (PFNA) Augmentation (with Traumacem V+)

Interventions

PFNA Augmentation (Synthes)

Proximal Femoral Nail Antirotation (PFNA) Augmentation (with Traumacem V+)

Intervention Type: DEVICE

PFNA (Synthes)

Proximal Femoral Nail Antirotation (PFNA)

Intervention Type: DEVICE

Other Intervention 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; PFNA length 240 mm; PFNA small length 200 mm; PFNA xs length 170 mm; PFNA long lengths 300-420 mm

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

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AO Clinical Investigation and Publishing Documentation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas Faeh

Role: STUDY_DIRECTOR

AO Clinical Investigation and Documentation, Davos, Switzerland

Christian Kammerlander, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Innsbruck, Austria

Locations

Medical University of Innsbruck

Innsbruck, , Austria

KUL Univ. Ziekenhuizen Leuven

Leuven, , Belgium

BGU Tübingen

Tübingen, , Germany

University of Ulm

Ulm, , Germany

Sophien und Hufeland Klinikum GmbH

Weimar, , Germany

Hadassah Medical Organization

Jerusalem, , Israel

Sykehuset i Vestfold HF Tønsberg

Tønsberg, , Norway

Cantonal Hospital Lucerne

Lucerne, , Switzerland

City Hospital Waid

Zurich, , Switzerland

Countries

Austria; Belgium; Germany; Israel; Norway; Switzerland

References

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.

Reference Type: RESULT

PMID: 29724590 (View on PubMed)

Other Identifiers

PFNA augmented

Identifier Type: -

Identifier Source: org_study_id