Clinical trial NCT00736684: Proximal Femoral Nail Antirotation™ (PFNA) Versus Gamma Nail 3™ (Gamma3) for Intramedullary Nailing of Unstable Trochanteric Fractures
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Unstable Trochanteric Fractures
Keywords: 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
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
Collaborators: name: Synthes Inc.
First posted: 2008-08-18
Enrollment: 440
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Any fracture fixation complication.
timeFrame: One year
Secondary outcomes:
measure: 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.
timeFrame: One year
Other outcomes:
Locations:
city: Santander
country: Spain
facility: Hospital Universitario "Marqués de Valdecilla"
state: Cantabria
city: Barcelona
country: Spain
facility: Hospital Clinic
state: Cataluña
city: Madrid
country: Spain
facility: Hospital Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
city: Murcia
country: Spain
facility: H.U. Virgen de la Arrixaca
city: San Sebastián
country: Spain
facility: Hospital Donostia
Study officials:
affiliation: AO Clinical Investigation and Documentation, Davos, Switzerland
name: Beate P. Hanson, MD
role: STUDY_DIRECTOR
affiliation: Hospital Gregorio Marañon, Madrid, Spain
name: Javier Vaquero Martin, MD
role: PRINCIPAL_INVESTIGATOR
References: