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

NCT06293495 | Not Yet Recruiting

• 1 other identifier: CUT-OUT
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Proximal Femoral Fractures

Keywords

Proximal femoral fracture; Hip fracture; Cut-out

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Functional Ambulatory Categories (FAC)

  0-6 months

• Tip-apex distance

  3-6 months

• Parker index

  3-6 months

• Baumgaertner reduction quality criteria

  3-6 months

• Number of Surgical complications (Intraoperative)

  0-1 month

Study Arms (2)

Single Cephalic Screw System

ACTIVE COMPARATOR

A Gamma 3 nail (single cephalic screw system) will be used for osteosynthesis of the fracture.

Device: Gamma 3 Nail (Stryker)

Double Cephalic Screw System

EXPERIMENTAL

A Chimaera nail (system with double cephalic screw) will be used for osteosynthesis of the fracture.

Device: Chimaera Nail (Orthofix)

Interventions

Gamma 3 Nail (Stryker) DEVICE

Open reduction an internal fixation of proximal femoral fracture with a Gamma 3 nail (single cephalic screw system)

Single Cephalic Screw System

Chimaera Nail (Orthofix) DEVICE

Open reduction an internal fixation of proximal femoral fracture with a Chimaera nail (system with double cephalic screw)

Double Cephalic Screw System

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Puerta de Hierro University Hospital: lead

Study Sites (1)

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

MeSH Terms

Conditions

Proximal Femoral Fractures; Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Neck Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Pedro José Torrijos Garrido, MD, PhD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro Jose Torrijos Garrido, MD, PhD

CONTACT

+34 91 191 74 85; pedrojose.torrijos@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, prospective trial with a CE-marked medical devices

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 5, 2024
• Study Start: March 1, 2024
• Primary Completion: September 30, 2025
• Study Completion: April 1, 2026
• Last Updated: March 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)