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

Comparison of the Incidence of Cut-out Between Intramedullary Nails With Double Cephalic Screw vs. Unique in Pertrochanteric Fractures: a Prospective Randomized Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Proximal Femoral Fractures
• Intervention / Treatment: Device: Gamma 3 Nail (Stryker); Device: Chimaera Nail (Orthofix)

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pedro Jose Torrijos Garrido, MD, PhD; Phone Number: +34 91 191 74 85; Email: pedrojose.torrijos@salud.madrid.org

Study Locations

• Spain
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro Majadahonda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single Cephalic Screw System; A Gamma 3 nail (single cephalic screw system) will be used for osteosynthesis of the fracture.	Device: Gamma 3 Nail (Stryker); Open reduction an internal fixation of proximal femoral fracture with a Gamma 3 nail (single cephalic screw system)
Experimental: Double Cephalic Screw System; A Chimaera nail (system with double cephalic screw) will be used for osteosynthesis of the fracture.	Device: Chimaera Nail (Orthofix); Open reduction an internal fixation of proximal femoral fracture with a Chimaera nail (system with double cephalic screw)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Puerta de Hierro University Hospital
• Investigators: Principal Investigator: Pedro José Torrijos Garrido, MD, PhD, Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Estimated): March 5, 2024

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Hip fracture; Cut-out; Proximal femoral fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone
• Other Study ID Numbers: CUT-OUT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No