Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT01473082
First received: November 10, 2011
Last updated: July 21, 2014
Last verified: July 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01473082

Locations
Austria
Medical University of Innsbruck
Innsbruck, Austria, 6020
Belgium
KUL Univ. Ziekenhuizen Leuven
Leuven, Belgium, 3000
Germany
BGU Tübingen
Tübingen, Germany, 72076
University of Ulm
Ulm, Germany, 89075
Sophien und Hufeland Klinikum GmbH
Weimar, Germany, 99425
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Norway
Sykehuset i Vestfold HF Tønsberg
Tønsberg, Norway, 3103
Switzerland
Cantonal Hospital Lucerne
Lucerne, Switzerland, 6000
City Hospital Waid
Zürich, Switzerland, 8037
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: July 21, 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 July 31, 2014