Incidence of Cut-out Using Intramedullary Nails With Double Cephalic Screw vs. Unique in Pertrochanteric Fractures

Not Applicable

Not yet recruiting

• Conditions: Proximal Femoral Fractures
• Interventions: Device: Chimaera Nail (Orthofix); Device: Gamma 3 Nail (Stryker)

• Registration Number: NCT06293495
• Lead Sponsor: Puerta de Hierro University Hospital

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.

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-20
• Study First Submitted QC: 2024-02-27
• Last Update Submitted: 2024-02-27
• Study Start: 2024-03-01
• Study First Posted: 2024-03-05
• Last Update Posted: 2024-03-05
• Primary Completion: 2025-09-30
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double Cephalic Screw System	Chimaera Nail (Orthofix)	A Chimaera nail (system with double cephalic screw) will be used for osteosynthesis of the fracture.
Single Cephalic Screw System	Gamma 3 Nail (Stryker)	A Gamma 3 nail (single cephalic screw system) will be used for osteosynthesis of the fracture.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Number of Surgical complications (Intraoperative)	0-1 month	Intraoperative complications
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.
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.

Trial Locations

Locations (1)

Hospital Universitario Puerta de Hierro Majadahonda; 🇪🇸 Majadahonda, Madrid, Spain