Proximal Femoral Fractures
Conditions
Keywords
Proximal femoral fracture, Hip fracture, Cut-out
Brief summary
The goal of this clinical trial is to compare outcomes in the treatment of proximal femur fractures. The main question it aims to answer is whether the use of a double cephalic screw prevents nail failure (cut-out). Participants will be treated using open reduction and internal fixation with a proximal femoral nail. Researchers will compare intramedullary nailing with a single cephalic screw (Gamma nail) and with a double cephalic screw (Chimaera nail) to see the cut-out rate.
Detailed description
Randomized, open and prospective clinical trial. Following the surgical indication for open reduction and internal fixation as treatment for proximal femoral fractures, patients will be randomly assigned (ratio 1:1) to one of the following treatments: Control group: a Gamma 3 nail (single cephalic screw system) will be used for osteosynthesis of the fracture. Experimental group: a Chimaera nail (system with double cephalic screw) will be used for osteosynthesis of the fracture. Patient (or their legal guardian) must provide/sign the informed consent prior to inclusion in the study. After the surgery, patients will be followed-up at 6 weeks, 3 and 6 months. At those times, data related to the radiological examination, the appearance of complications and the walking ability evaluation scale (FAC) will be collected.
Interventions
DEVICEGamma 3 Nail (Stryker)
Open reduction an internal fixation of proximal femoral fracture with a Gamma 3 nail (single cephalic screw system)
DEVICEChimaera Nail (Orthofix)
Open reduction an internal fixation of proximal femoral fracture with a Chimaera nail (system with double cephalic screw)
Sponsors
Puerta de Hierro University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, prospective trial with a CE-marked medical devices
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with proximal femur fracture (OTA/AO 31-A1, A2 and A3) requiring surgical treatment. * Signing of written informed consent according to current legislation before collecting any information, either by the patient or by the legal representative or by people linked by family ties.
Exclusion criteria
* Presence of other fractures in the ipsilateral femur that condition the surgical treatment of the pertrochanteric femur fracture. * Subcapital fracture of the proximal femur. * Subtrochanteric fracture of the proximal femur. * Pathological fracture.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of cut-out. | 0-6 months | Cut-out is a mechanical complication consisting of varus collapse and migration of the cephalic screw through the femoral head. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tip-apex distance | 3-6 months | Distance from the tip of the screw to the apex of the femoral head in the anteroposterior and axial views. |
| Parker index | 3-6 months | Indicates the distance of the screw from the inferior edge of the femoral neck in anteroposterior view or from the posterior edge of the femoral neck in lateral view. |
| Functional Ambulatory Categories (FAC) | 0-6 months | Classifies patients into 6 categories based on their ability and need for assistance with ambulation. Classifies patients into 6 categories based on their ability and need for help with ambulation, where 0 is equivalent to a patient with the impossibility of ambulation and 5 is a patient completely independent for ambulation. |
| Number of Surgical complications (Intraoperative) | 0-1 month | Intraoperative complications |
| Number of Surgical complications (post-operative) | 0-6 months | Postoperative complications |
| Baumgaertner reduction quality criteria | 3-6 months | 3 groups are established according to the quality of reduction: good, acceptable and bad |
Countries
Spain
Contacts
Primary ContactPedro Jose Torrijos Garrido, MD, PhD
Outcome results
None listed