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

Unstable Trochanteric Fractures Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00736684
• Other study ID #: PROGAINT-ES-08
• Status: Completed
• Phase: Phase 4
• First received: August 15, 2008
• Last updated: February 10, 2011
• Start date: November 2007
• Est. completion date: September 2010

Study information

• Verified date: February 2011
• Source: AO Clinical Investigation and Documentation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: September 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• Unstable Trochanteric Fractures

Intervention

Device:
• Proximal Femoral Nail AntirotationTM (PFNA)
intramedullary nailing
• Gamma Nail 3TM (Gamma3)
intramedullary nailing

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona	Cataluña
Spain	Hospital Gregorio Marañon	Madrid
Spain	Hospital Puerta de Hierro	Madrid
Spain	H.U. Virgen de la Arrixaca	Murcia
Spain	Hospital Donostia	San Sebastián
Spain	Hospital Universitario "Marqués de Valdecilla"	Santander	Cantabria

Sponsors (2)

Lead Sponsor	Collaborator
AO Clinical Investigation and Documentation	Synthes Inc.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any fracture fixation complication.		One year	No
Secondary	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	No