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Proximal Femoral Nail Antirotation™ (PFNA) Versus Gamma Nail 3™ (Gamma3) for Intramedullary Nailing of Unstable Trochanteric Fractures (PROGAINT-ES)

Primary Purpose

Unstable Trochanteric Fractures

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Proximal Femoral Nail AntirotationTM (PFNA)
Gamma Nail 3TM (Gamma3)
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 Unstable Trochanteric Fractures focused on measuring Femoral fractures [MeSH], hip fractures [MeSH], trochanteric fractures (femoral neck fractures [MeSH]), intramedullary nailing (fracture fixation, intramedullary [MeSH]), complex femoral fractures, femoral nail, surgical treatment (surgical procedures, operative [MeSH]), complications

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 55 years and more
  • Patients with isolated, unstable, closed or type 1 open trochanteric fractures, classified as AO 31-A2 or AO 31-A3
  • Definitive primary fracture treatment with PFNA or Gamma3 (defined inTable 1) within three days after the index event
  • Signed written informed consent (by the subjects or legal guardian) and agreement to attend the planned follow-ups

Exclusion Criteria:

  • Pathologic fracture of any other cause than osteoporosis
  • Patients or legal guardian refusing to sign the informed consent form
  • Multiple trauma
  • Type 2 and 3 open fractures
  • Drug or alcohol abuse
  • Wound and/or bone healing disorders of any other cause than diabetes mellitus or smoking
  • Active malignancy
  • Expected life expectancy ≤ 3 months
  • Inability to walk independently prior to injury event (use of one stick is allowed. Not meeting inclusion criteria are bedridden, wheel-chair ridden and walker dependent subjects)
  • Neurological and psychiatric disorders that would preclude reliable assessment (eg,, Parkinson disease, Multiple sclerosis, severe depression)
  • Rheumatoid arthritis

Sites / Locations

  • Hospital Universitario "Marqués de Valdecilla"
  • Hospital Clinic
  • Hospital Gregorio Marañon
  • Hospital Puerta de Hierro
  • H.U. Virgen de la Arrixaca
  • Hospital Donostia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

1

2

Arm Description

Proximal Femoral Nail AntirotationTM (PFNA)

Gamma Nail 3TM (Gamma3)

Outcomes

Primary Outcome Measures

Any fracture fixation complication.

Secondary Outcome Measures

Bone union/fusion as evaluated by CT-scanning, health-related quality of life, disease-specific functional scoring, activities of daily living, mortality, radiological parameters, surgery details and surgeons' evaluation of handling and effectiveness.

Full Information

First Posted
August 15, 2008
Last Updated
February 10, 2011
Sponsor
AO Clinical Investigation and Publishing Documentation
Collaborators
Synthes Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00736684
Brief Title
Proximal Femoral Nail Antirotation™ (PFNA) Versus Gamma Nail 3™ (Gamma3) for Intramedullary Nailing of Unstable Trochanteric Fractures
Acronym
PROGAINT-ES
Official Title
Proximal Femoral Nail Antirotation™ (PFNA) Versus Gamma Nail 3™ (Gamma3) for Intramedullary Nailing of Unstable Trochanteric Fractures - a Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AO Clinical Investigation and Publishing Documentation
Collaborators
Synthes Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare rates of any fracture fixation complication and revision rates after intramedullary fixation of unstable trochanteric fractures between the Proximal Femoral Nail Antirotation™ (PFNA)(Investigational Group) and Gamma Nail 3™ (Gamma3) (Control Group).
Detailed Description
Intramedullary nailing of unstable per- and subtrochanteric femoral fractures is a standard procedure in trauma and orthopaedic surgery. Unstable fractures treated with intramedullary nailing carry the risk of fracture fixation complications. The PFNA (Synthes) has evolved from the original PFN design, featuring a novel antirotation screw. Apart from the prevention of excess rotational forces, this supporting element may enhance the overall stability of the construct, thus potentially reducing fracture fixation complications. Empirical information about the fracture fixation complication rates of the PFNA device is not available. The primary objective of this study is to compare the 1-year fracture fixation rates between the PFNA and Gamma Nail 3™ (Stryker). Secondary objectives of the study are to compare differences in functional outcomes, quality of life outcomes, safety, radiological outcomes, handling and perceived effectiveness between the devices.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unstable Trochanteric Fractures
Keywords
Femoral fractures [MeSH], hip fractures [MeSH], trochanteric fractures (femoral neck fractures [MeSH]), intramedullary nailing (fracture fixation, intramedullary [MeSH]), complex femoral fractures, femoral nail, surgical treatment (surgical procedures, operative [MeSH]), complications

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Proximal Femoral Nail AntirotationTM (PFNA)
Arm Title
2
Arm Type
Other
Arm Description
Gamma Nail 3TM (Gamma3)
Intervention Type
Device
Intervention Name(s)
Proximal Femoral Nail AntirotationTM (PFNA)
Intervention Description
intramedullary nailing
Intervention Type
Device
Intervention Name(s)
Gamma Nail 3TM (Gamma3)
Intervention Description
intramedullary nailing
Primary Outcome Measure Information:
Title
Any fracture fixation complication.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Bone union/fusion as evaluated by CT-scanning, health-related quality of life, disease-specific functional scoring, activities of daily living, mortality, radiological parameters, surgery details and surgeons' evaluation of handling and effectiveness.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 55 years and more Patients with isolated, unstable, closed or type 1 open trochanteric fractures, classified as AO 31-A2 or AO 31-A3 Definitive primary fracture treatment with PFNA or Gamma3 (defined inTable 1) within three days after the index event Signed written informed consent (by the subjects or legal guardian) and agreement to attend the planned follow-ups Exclusion Criteria: Pathologic fracture of any other cause than osteoporosis Patients or legal guardian refusing to sign the informed consent form Multiple trauma Type 2 and 3 open fractures Drug or alcohol abuse Wound and/or bone healing disorders of any other cause than diabetes mellitus or smoking Active malignancy Expected life expectancy ≤ 3 months Inability to walk independently prior to injury event (use of one stick is allowed. Not meeting inclusion criteria are bedridden, wheel-chair ridden and walker dependent subjects) Neurological and psychiatric disorders that would preclude reliable assessment (eg,, Parkinson disease, Multiple sclerosis, severe depression) Rheumatoid arthritis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beate P. Hanson, MD
Organizational Affiliation
AO Clinical Investigation and Documentation, Davos, Switzerland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Javier Vaquero Martin, MD
Organizational Affiliation
Hospital Gregorio Marañon, Madrid, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario "Marqués de Valdecilla"
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Clinic
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Puerta de Hierro
City
Madrid
ZIP/Postal Code
28035
Country
Spain
Facility Name
H.U. Virgen de la Arrixaca
City
Murcia
ZIP/Postal Code
30071
Country
Spain
Facility Name
Hospital Donostia
City
San Sebastián
ZIP/Postal Code
20014
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Proximal Femoral Nail Antirotation™ (PFNA) Versus Gamma Nail 3™ (Gamma3) for Intramedullary Nailing of Unstable Trochanteric Fractures

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