Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation

This study is currently recruiting participants.
Verified March 2014 by AO Clinical Investigation and Documentation
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT01473082
First received: November 10, 2011
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Hip Fractures
Closed Fracture of Hip
Device: PFNA Augmentation (Synthes)
Device: PFNA (Synthes)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation for the Treatment of Closed Unstable Trochanteric Fractures - A Randomized-controlled Trial

Resource links provided by NLM:


Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:
  • Mobility measured with the "timed up & go"-test during hospital stay. [ Time Frame: 5 to 7 days postoperative ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Description of surgical details as surgery time and fluoroscopy time, and of augmentation details (PFNA Augmentation group only). [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: one year ] [ Designated as safety issue: No ]
    Pain, measured with the Numerical Rating Scale (NRS) and use of pain medication postoperative.

  • Duration of hospital stay [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Walking ability [ Time Frame: one year ] [ Designated as safety issue: No ]
    Parker Mobility Score

  • Return to pre-fracture residential status [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Timed up & go-test at follow-ups [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.

  • Quality of life [ Time Frame: one year ] [ Designated as safety issue: No ]
    EuroQol-5D

  • Local adverse events and revision rate [ Time Frame: one year ] [ Designated as safety issue: No ]
    Implant / surgery, bone / fracture, soft tissue of the musculoskeletal system, wound related adverse events

  • Systemic adverse events [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Implant migration [ Time Frame: one year ] [ Designated as safety issue: No ]
    Measured at the CT in a subgroup only

  • Mortality [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Fracture risk prior to injury [ Time Frame: 1 week prior to operation ] [ Designated as safety issue: No ]
    Measured with the Fracture Risk Assessment Tool (FRAX)

  • Functional independence [ Time Frame: 1 week prior to operation ] [ Designated as safety issue: No ]
    Measured with the Barthel Index

  • Comorbidity [ Time Frame: 1 week prior to operation ] [ Designated as safety issue: No ]
    Charlson Comorbidiy Index


Estimated Enrollment: 234
Study Start Date: February 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Synthes) Augmentation (with Traumacem V+ Synthes)
Device: PFNA Augmentation (Synthes)
Proximal Femoral Nail Antirotation (PFNA) Augmentation (with Traumacem V+)
Other Names:
  • PFNA length 240 mm
  • PFNA small length 200 mm
  • PFNA xs length 170 mm
  • PFNA long lengths 300-420 mm

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

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01473082

Contacts
Contact: Jan Ljungqvist +41 44 200 24 61 jan.ljungqvist@aofoundation.org

Locations
Austria
Medical University of Innsbruck Recruiting
Innsbruck, Austria, 6020
Contact: Christian Kammerlander, MD    +43 512 504 80882    Christian.Kammerlander@uki.at   
Belgium
KUL Univ. Ziekenhuizen Leuven Recruiting
Leuven, Belgium, 3000
Contact: An Sermon, MD       an.sermon@uzleuven.be   
Germany
BGU Tübingen Recruiting
Tübingen, Germany, 72076
Contact: Dankward Höntzsch, MD         
Contact: Matthias Baumann, MD         
University of Ulm Recruiting
Ulm, Germany, 89075
Contact: Florian Gebhard, MD       florian.gebhard@uniklinik-ulm.de   
Sophien und Hufeland Klinikum GmbH Recruiting
Weimar, Germany, 99425
Contact: Olaf Bach, MD       O.Bach@Klinikum-Weimar.de   
Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel, 91120
Contact: Yoram Weill, MD       WeilY@hadassah.org.il   
Norway
Sykehuset i Vestfold HF Tønsberg Recruiting
Tønsberg, Norway, 3103
Contact: Sturla Hem, MD       einhehe@online.no   
Switzerland
Cantonal Hospital Lucerne Recruiting
Lucerne, Switzerland, 6000
Contact: Reto Babst, MD       reto.babst@ksl.ch   
City Hospital Waid Recruiting
Zürich, Switzerland, 8037
Contact: Christoph Meier, MD       christoph.meier@waid.zuerich.ch   
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Investigators
Study Director: Beate P. Hanson, MD AO Clinical Investigation and Documentation, Davos, Switzerland
Principal Investigator: Christian Kammerlander, MD Medical University of Innsbruck, Austria
  More Information

No publications provided

Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT01473082     History of Changes
Other Study ID Numbers: PFNA augmented
Study First Received: November 10, 2011
Last Updated: March 18, 2014
Health Authority: Austria: Ethikkommission
Belgium: Ethics Committee
Germany: Ethics Commission
Israel: Ethics Commission
Norway: Ethics Committee
Switzerland: Ethikkommission

Additional relevant MeSH terms:
Fractures, Bone
Fractures, Closed
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on April 23, 2014