Unstable Trochanteric Fractures
Conditions
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
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.
Interventions
DEVICEProximal Femoral Nail AntirotationTM (PFNA)
intramedullary nailing
DEVICEGamma Nail 3TM (Gamma3)
intramedullary nailing
Sponsors
Synthes Inc.
AO Clinical Investigation and Publishing Documentation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any fracture fixation complication. | One year |
Secondary
| 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 |
Countries
Spain
Outcome results
None listed