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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00736684
Recruitment Status : Completed
First Posted : August 18, 2008
Last Update Posted : February 11, 2011
Sponsor:
Collaborator:
Synthes Inc.
Information provided by:
AO Innovation Translation Center

Tracking Information
First Submitted Date  ICMJE August 15, 2008
First Posted Date  ICMJE August 18, 2008
Last Update Posted Date February 11, 2011
Study Start Date  ICMJE November 2007
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2008)
Any fracture fixation complication. [ Time Frame: One year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Proximal Femoral Nail Antirotation™ (PFNA) Versus Gamma Nail 3™ (Gamma3) for Intramedullary Nailing of Unstable Trochanteric Fractures
Official Title  ICMJE Proximal Femoral Nail Antirotation™ (PFNA) Versus Gamma Nail 3™ (Gamma3) for Intramedullary Nailing of Unstable Trochanteric Fractures - a Multicenter Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Unstable Trochanteric Fractures
Intervention  ICMJE
  • Device: Proximal Femoral Nail AntirotationTM (PFNA)
    intramedullary nailing
  • Device: Gamma Nail 3TM (Gamma3)
    intramedullary nailing
Study Arms  ICMJE
  • Active Comparator: 1
    Proximal Femoral Nail AntirotationTM (PFNA)
    Intervention: Device: Proximal Femoral Nail AntirotationTM (PFNA)
  • 2
    Gamma Nail 3TM (Gamma3)
    Intervention: Device: Gamma Nail 3TM (Gamma3)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 15, 2008)
440
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00736684
Other Study ID Numbers  ICMJE PROGAINT-ES-08
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Javier Vaquero Martin, MD, Hospital Gregorio Marañon
Study Sponsor  ICMJE AO Clinical Investigation and Documentation
Collaborators  ICMJE Synthes Inc.
Investigators  ICMJE
Study Director: Beate P. Hanson, MD AO Clinical Investigation and Documentation, Davos, Switzerland
Principal Investigator: Javier Vaquero Martin, MD Hospital Gregorio Marañon, Madrid, Spain
PRS Account AO Innovation Translation Center
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP