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Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation

Primary Purpose

Hip Fractures, Closed Fracture of Hip

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
PFNA Augmentation (Synthes)
PFNA (Synthes)
Sponsored by
AO Clinical Investigation and Publishing Documentation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Innsbruck
  • KUL Univ. Ziekenhuizen Leuven
  • BGU Tübingen
  • University of Ulm
  • Sophien und Hufeland Klinikum GmbH
  • Hadassah Medical Organization
  • Sykehuset i Vestfold HF Tønsberg
  • Cantonal Hospital Lucerne
  • City Hospital Waid

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PFNA

PFNA Augmentation

Arm Description

Proximal Femoral Nail Antirotation (PFNA Synthes)

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Description of surgical details as surgery time and fluoroscopy time, and of augmentation details (PFNA Augmentation group only).
Pain
Pain, measured with the Numerical Rating Scale (NRS) and use of pain medication postoperative.
Duration of hospital stay
Walking ability
Parker Mobility Score
Return to pre-fracture residential status
Timed up & go-test at follow-ups
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
EuroQol-5D
Local adverse events and revision rate
Implant / surgery, bone / fracture, soft tissue of the musculoskeletal system, wound related adverse events
Systemic adverse events
Implant migration
Measured at the CT in a subgroup only
Mortality
Fracture risk prior to injury
Measured with the Fracture Risk Assessment Tool (FRAX)
Functional independence
Measured with the Barthel Index
Comorbidity
Charlson Comorbidiy Index

Full Information

First Posted
November 10, 2011
Last Updated
August 11, 2020
Sponsor
AO Clinical Investigation and Publishing Documentation
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1. Study Identification

Unique Protocol Identification Number
NCT01473082
Brief Title
Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation
Official Title
Comparison of Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation for the Treatment of Closed Unstable Trochanteric Fractures - A Randomized-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AO Clinical Investigation and Publishing Documentation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Closed Fracture of Hip

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
251 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PFNA
Arm Type
Active Comparator
Arm Description
Proximal Femoral Nail Antirotation (PFNA Synthes)
Arm Title
PFNA Augmentation
Arm Type
Active Comparator
Arm Description
Proximal Femoral Nail Antirotation PFNA Augmentation (Synthes) with Traumacem V+ Synthes
Intervention Type
Device
Intervention Name(s)
PFNA Augmentation (Synthes)
Other Intervention Name(s)
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
Intervention Description
Proximal Femoral Nail Antirotation (PFNA) Augmentation (with Traumacem V+)
Intervention Type
Device
Intervention Name(s)
PFNA (Synthes)
Other Intervention Name(s)
PFNA length 240 mm, PFNA small length 200 mm, PFNA xs length 170 mm, PFNA long lengths 300-420 mm
Intervention Description
Proximal Femoral Nail Antirotation (PFNA)
Primary Outcome Measure Information:
Title
Mobility measured with the "timed up & go"-test during hospital stay.
Description
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.
Time Frame
5 to 7 days postoperative
Secondary Outcome Measure Information:
Title
Description of surgical details as surgery time and fluoroscopy time, and of augmentation details (PFNA Augmentation group only).
Time Frame
Intraoperative
Title
Pain
Description
Pain, measured with the Numerical Rating Scale (NRS) and use of pain medication postoperative.
Time Frame
one year
Title
Duration of hospital stay
Time Frame
one year
Title
Walking ability
Description
Parker Mobility Score
Time Frame
one year
Title
Return to pre-fracture residential status
Time Frame
one year
Title
Timed up & go-test at follow-ups
Description
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.
Time Frame
one year
Title
Quality of life
Description
EuroQol-5D
Time Frame
one year
Title
Local adverse events and revision rate
Description
Implant / surgery, bone / fracture, soft tissue of the musculoskeletal system, wound related adverse events
Time Frame
one year
Title
Systemic adverse events
Time Frame
one year
Title
Implant migration
Description
Measured at the CT in a subgroup only
Time Frame
one year
Title
Mortality
Time Frame
one year
Title
Fracture risk prior to injury
Description
Measured with the Fracture Risk Assessment Tool (FRAX)
Time Frame
1 week prior to operation
Title
Functional independence
Description
Measured with the Barthel Index
Time Frame
1 week prior to operation
Title
Comorbidity
Description
Charlson Comorbidiy Index
Time Frame
1 week prior to operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Faeh
Organizational Affiliation
AO Clinical Investigation and Documentation, Davos, Switzerland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Christian Kammerlander, MD
Organizational Affiliation
Medical University of Innsbruck, Austria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
KUL Univ. Ziekenhuizen Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
BGU Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
University of Ulm
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Facility Name
Sophien und Hufeland Klinikum GmbH
City
Weimar
ZIP/Postal Code
99425
Country
Germany
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Sykehuset i Vestfold HF Tønsberg
City
Tønsberg
ZIP/Postal Code
3103
Country
Norway
Facility Name
Cantonal Hospital Lucerne
City
Lucerne
ZIP/Postal Code
6000
Country
Switzerland
Facility Name
City Hospital Waid
City
Zürich
ZIP/Postal Code
8037
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
29724590
Citation
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.
Results Reference
result

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Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation

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