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

• ClinicalTrials.gov Identifier: NCT00736684
• Recruitment Status: Completed
• First Posted: August 18, 2008
• Last Update Posted: February 11, 2011
• Sponsor: AO Clinical Investigation and Documentation
• Collaborator: Synthes Inc.
• Information provided by: AO Innovation Translation Center

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).

Condition or disease	Intervention/treatment	Phase
Unstable Trochanteric Fractures	Device: Proximal Femoral Nail AntirotationTM (PFNA); Device: Gamma Nail 3TM (Gamma3)	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 440 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: November 2007
• Actual Primary Completion Date: September 2009
• Actual Study Completion Date: September 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Any fracture fixation complication. [ Time Frame: One year ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 55 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Spain

Hospital Universitario "Marqués de Valdecilla"

Santander, Cantabria, Spain, 39008

Hospital Clinic

Barcelona, Cataluña, Spain, 08036

Hospital Gregorio Marañon

Madrid, Spain, 28007

Hospital Puerta de Hierro

Madrid, Spain, 28035

H.U. Virgen de la Arrixaca

Murcia, Spain, 30071

Hospital Donostia

San Sebastián, Spain, 20014

Sponsors and Collaborators

AO Clinical Investigation and Documentation

Synthes Inc.

Investigators

• Study Director: Beate P. Hanson, MD; AO Clinical Investigation and Documentation, Davos, Switzerland
• Principal Investigator: Javier Vaquero Martin, MD; Hospital Gregorio Marañon, Madrid, Spain

More Information

• Responsible Party: Javier Vaquero Martin, MD, Hospital Gregorio Marañon
• ClinicalTrials.gov Identifier: NCT00736684
• Other Study ID Numbers: PROGAINT-ES-08
• First Posted: August 18, 2008
• Last Update Posted: February 11, 2011
• Last Verified: February 2011

Keywords provided by AO Innovation Translation Center:

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

Additional relevant MeSH terms:

Fractures, Bone; Hip Fractures; Wounds and Injuries; Femoral Fractures; Hip Injuries; Leg Injuries