Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation

August 11, 2020 updated by: AO Clinical Investigation and Publishing Documentation

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
251

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mobility measured with the "timed up & go"-test during hospital stay.
Time Frame: 5 to 7 days postoperative
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: one year
one year
Description of surgical details as surgery time and fluoroscopy time, and of augmentation details (PFNA Augmentation group only).
Time Frame: Intraoperative
Intraoperative
Pain
Time Frame: one year
Pain, measured with the Numerical Rating Scale (NRS) and use of pain medication postoperative.
one year
Duration of hospital stay
Time Frame: one year
one year
Walking ability
Time Frame: one year
Parker Mobility Score
one year
Return to pre-fracture residential status
Time Frame: one year
one year
Timed up & go-test at follow-ups
Time Frame: one year
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
Time Frame: one year
EuroQol-5D
one year
Local adverse events and revision rate
Time Frame: one year
Implant / surgery, bone / fracture, soft tissue of the musculoskeletal system, wound related adverse events
one year
Systemic adverse events
Time Frame: one year
one year
Implant migration
Time Frame: one year
Measured at the CT in a subgroup only
one year
Fracture risk prior to injury
Time Frame: 1 week prior to operation
Measured with the Fracture Risk Assessment Tool (FRAX)
1 week prior to operation
Functional independence
Time Frame: 1 week prior to operation
Measured with the Barthel Index
1 week prior to operation
Comorbidity
Time Frame: 1 week prior to operation
Charlson Comorbidiy Index
1 week prior to operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AO Clinical Investigation and Publishing Documentation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PFNA augmented

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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