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

AO Clinical Investigation and Publishing Documentation

Status and phase

Completed

Phase 4

Conditions

Unstable Trochanteric Fractures

Treatments

Device: Proximal Femoral Nail AntirotationTM (PFNA)

Device: Gamma Nail 3TM (Gamma3)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00736684

PROGAINT-ES-08

Details and patient eligibility

About

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).

Full 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.

Enrollment

440 estimated patients

Sex

All

Ages

55+ years old

Volunteers

Accepts 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