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OpenTrials
Terminated

NCT Number: NCT06293495

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

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.

Why the study stopped: The study was terminated early because of limited clinical use of the intramedullary nail with two cephalic screws, resulting in insufficient participant recruitment.
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Key information

Conditions

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

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gamma 3 Nail (Stryker)

Device

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

Primary outcomes

  1. Incidence of cut-out.

    Time frame: 0-6 months

    Cut-out is a mechanical complication consisting of varus collapse and migration of the cephalic screw through the femoral head.

Secondary outcomes

  1. Functional Ambulatory Categories (FAC)

    Time frame: 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.

  2. Tip-apex distance

    Time frame: 3-6 months

    Distance from the tip of the screw to the apex of the femoral head in the anteroposterior and axial views.

  3. Parker index

    Time frame: 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.

  4. Baumgaertner reduction quality criteria

    Time frame: 3-6 months

    3 groups are established according to the quality of reduction: good, acceptable and bad

  5. Number of Surgical complications (Intraoperative)

    Time frame: 0-1 month

    Intraoperative complications

  6. Number of Surgical complications (post-operative)

    Time frame: 0-6 months

    Postoperative complications

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Puerta de Hierro University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 5, 2024
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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