Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation

NCT01473082 | Completed Phase 4 DMC

• 1 other identifier: PFNA augmented
• Study Type: interventional
• Target: 251
• Locations: 6 countries
• Sites: 9

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.

Conditions

Hip Fractures; Closed Fracture of Hip

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Description of surgical details as surgery time and fluoroscopy time, and of augmentation details (PFNA Augmentation group only).

  Intraoperative

• Pain

  one year

• Duration of hospital stay

  one year

• Walking ability

  one year

• Return to pre-fracture residential status

  one year

Study Arms (2)

PFNA

ACTIVE COMPARATOR

Proximal Femoral Nail Antirotation (PFNA Synthes)

Device: PFNA (Synthes)

PFNA Augmentation

ACTIVE COMPARATOR

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

Device: PFNA Augmentation (Synthes)

Interventions

PFNA Augmentation (Synthes) DEVICE

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

Also known as: 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 Augmentation

PFNA (Synthes) DEVICE

Proximal Femoral Nail Antirotation (PFNA)

Also known as: PFNA length 240 mm, PFNA small length 200 mm, PFNA xs length 170 mm, PFNA long lengths 300-420 mm

PFNA

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AO Clinical Investigation and Publishing Documentation: lead

Study Sites (9)

Medical University of Innsbruck

Innsbruck, 6020, Austria

Location

KUL Univ. Ziekenhuizen Leuven

Leuven, 3000, Belgium

Location

BGU Tübingen

Tübingen, 72076, Germany

Location

University of Ulm

Ulm, 89075, Germany

Location

Sophien und Hufeland Klinikum GmbH

Weimar, 99425, Germany

Location

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

Sykehuset i Vestfold HF Tønsberg

Tønsberg, 3103, Norway

Location

Cantonal Hospital Lucerne

Lucerne, 6000, Switzerland

Location

City Hospital Waid

Zurich, 8037, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 29724590 RESULT

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Andreas Faeh

  AO Clinical Investigation and Documentation, Davos, Switzerland

  STUDY DIRECTOR

• Christian Kammerlander, MD

  Medical University of Innsbruck, Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2011
• First Posted: November 17, 2011
• Study Start: February 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: August 13, 2020

Record last verified: 2018-07

Locations

AU (1); DE (3); NO (1); CH (2); BE (1); IL (1)