Clinical trial NCT06293495: Incidence of Cut-out Using Intramedullary Nails With Double Cephalic Screw vs. Unique in Pertrochanteric Fractures
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Proximal Femoral Fractures
Keywords: Proximal femoral fracture
Hip fracture
Cut-out
Lead sponsor: Puerta de Hierro University Hospital
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 200
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, prospective trial with a CE-marked medical devices
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of cut-out.
timeFrame: 0-6 months
Secondary outcomes:
measure: Functional Ambulatory Categories (FAC)
timeFrame: 0-6 months
measure: Tip-apex distance
timeFrame: 3-6 months
measure: Parker index
timeFrame: 3-6 months
measure: Baumgaertner reduction quality criteria
timeFrame: 3-6 months
measure: Number of Surgical complications (Intraoperative)
timeFrame: 0-1 month
measure: Number of Surgical complications (post-operative)
timeFrame: 0-6 months
Other outcomes:
Locations:
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
Study officials:
affiliation: Study Principal Investigator
name: Pedro José Torrijos Garrido, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: