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

Proximal Femoral Nail Antirotation™ (PFNA) Versus Gamma Nail 3™ (Gamma3) for Intramedullary Nailing of Unstable Trochanteric Fractures - a Multicenter Randomized Controlled Trial

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).

Study Overview

• Status: Completed
• Conditions: Unstable Trochanteric Fractures
• Intervention / Treatment: Device: Proximal Femoral Nail AntirotationTM (PFNA); Device: Gamma Nail 3TM (Gamma3)

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: Interventional
• Enrollment (Anticipated): 440
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28007
    • Hospital Gregorio Maranon
  • Madrid, Spain, 28035
    • Hospital Puerta de Hierro
  • Murcia, Spain, 30071
    • H.U. Virgen de la Arrixaca
  • San Sebastián, Spain, 20014
    • Hospital Donostia
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario "Marqués de Valdecilla"
  • Cataluña
    • Barcelona, Cataluña, Spain, 08036
      • Hospital Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Proximal Femoral Nail AntirotationTM (PFNA)	Device: Proximal Femoral Nail AntirotationTM (PFNA); intramedullary nailing
Other: 2; Gamma Nail 3TM (Gamma3)	Device: Gamma Nail 3TM (Gamma3); intramedullary nailing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Any fracture fixation complication.	One year

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	One year

Collaborators and Investigators

• Sponsor: AO Clinical Investigation and Publishing Documentation
• Collaborators: Synthes Inc.
• Investigators: Principal Investigator: Javier Vaquero Martin, MD, Hospital Gregorio Marañón, Madrid, Spain

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: August 15, 2008
• First Submitted That Met QC Criteria: August 15, 2008
• First Posted (Estimate): August 18, 2008

Study Record Updates

• Last Update Posted (Estimate): February 11, 2011
• Last Update Submitted That Met QC Criteria: February 10, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: complications; 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])
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: PROGAINT-ES-08