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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Cephalic Screw System | Active Comparator | A Gamma 3 nail (single cephalic screw system) will be used for osteosynthesis of the fracture. |
|
| Double Cephalic Screw System | Experimental | A Chimaera nail (system with double cephalic screw) will be used for osteosynthesis of the fracture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gamma 3 Nail (Stryker) | Device | Open reduction an internal fixation of proximal femoral fracture with a Gamma 3 nail (single cephalic screw system) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of cut-out. | Cut-out is a mechanical complication consisting of varus collapse and migration of the cephalic screw through the femoral head. | 0-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Ambulatory Categories (FAC) | 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. | 0-6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pedro Jose Torrijos Garrido, MD, PhD | Contact | +34 91 191 74 85 | pedrojose.torrijos@salud.madrid.org |
| Name | Affiliation | Role |
|---|---|---|
| Pedro José Torrijos Garrido, MD, PhD | Study Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid | 28222 | Spain |
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| ID | Term |
|---|---|
| D000092526 | Proximal Femoral Fractures |
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005265 | Femoral Neck Fractures |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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Randomized, prospective trial with a CE-marked medical devices
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| Chimaera Nail (Orthofix) | Device | Open reduction an internal fixation of proximal femoral fracture with a Chimaera nail (system with double cephalic screw) |
|
| Tip-apex distance | Distance from the tip of the screw to the apex of the femoral head in the anteroposterior and axial views. | 3-6 months |
| Parker index | 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. | 3-6 months |
| Baumgaertner reduction quality criteria | 3 groups are established according to the quality of reduction: good, acceptable and bad | 3-6 months |
| Number of Surgical complications (Intraoperative) | Intraoperative complications | 0-1 month |
| Number of Surgical complications (post-operative) | Postoperative complications | 0-6 months |
| D025981 |
| Hip Injuries |
| D007869 | Leg Injuries |