Influence of Cemented Cephalic Augmentation on the Outcome of Intramedullary Nailing in Pertrochanteric Hip Fractures

NCT ID: NCT06634290

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 314 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2026-09-30

Brief Summary

The goal of this clinical trial is to learn if small modifications in the surgical technique for the treatment of some kind of hip fractures, improve the result of the surgery. This small modification includes the addition of surgical bone cement to part of the intramedullary nail used in the surgery, to find out if it provides more stability to the construct and represents an improvement in the surgery result.

The main question it aims to answer is:

Does the addition of bone cement produces a decrease in complications related to mechanical failure of the implant used in the surgery and a decrease in the need for re-operation?

Researchers will compare adding this bone cement to the standard surgical technique without it.

Patients will:

• Be randomly assigned to a group that will have surgery following standard protocol or to a group that will have surgery following standard protocol but adding bone cement to the construct.
• Receive standard care for these fractures during hospitalization and posterior follow-up checkups for a year.

Detailed Description

Hypothesis

The hypothesis of the study assumes that cephalic augmentation with polymethylmethacrylate cement of the intramedullary nail in the surgical treatment of pertrochanteric hip fractures due to fragility, produces a decrease in complications in relation to mechanical failure of the implant and a decrease in the re-operation rate.

Objectives

The main objective seeks to compare the mechanical failure rates of the implant between intramedullary nailing with and without cephalic augmentation with polymethylmethacrylate cement.

The secondary objectives are to compare the perioperative, 1-month, and 1-year mortality rates of patients treated with intramedullary nailing with and without cephalic augmentation and to evaluate the safety of the surgical technique.

Design

For these purposes, a multicenter, controlled, randomized, single-blind, parallel groups, clinical trial will be carried out.

Participants

Patients over 75 years old, diagnosed with pertrochanteric hip fracture due and requiring surgical intervention, will be eligible for inclusion in the study. All patients will receive surgical treatment using the intramedullary nailing technique, which is the current gold standard treatment for this type of fractures.

Recruitment

Almost all patients who suffer a hip fracture require urgent attention for this process, as well as hospital admission. From the first moment of admission through the emergency room or during the time of hospitalization prior to surgery, the patient and/or their legal representative, will receive pertinent information about the diagnosis, prognosis and treatment of this pathology by and Orthopedic Surgeon.

At the same time that they receive this information, either the principal investigator, or one of the collaborating researchers, will additionally provide information about the study and will recruit patients to participate in it. Prior to the surgery, informed consent will be granted to participate in the research study and the corresponding documents will be signed, along with the usual surgical informed consent used in each institution for this specific pathology,

Given the characteristics of this pathology and the benefit it represents in terms of functional recovery and improved survival, if the surgical intervention is performed in the first 48 hours from the occurrence of the fracture, in some of the patients participating in the study, it may be the case that the operation is performed in less than 24 hours from the acceptance and signing of the informed consent.

Randomization

The patients included in the study will be randomly distributed into two groups, experimental and control. The experimental or CEMENT group will include patients treated with intramedullary nailing WITH cephalic augmentation, and the control or NO CEMENT group will include patients treated with intramedullary nailing WITHOUT cephalic augmentation. Once participation in the study has been accepted and the informed consents have been signed, the randomization process will proceed in the different groups as follows.

The use of a centralized computer system that generates the randomization sequence and performs the registration of the participants, concealment of the randomization sequence and group allocation, is currently the most recommended procedure for conducting clinical trials. For this study, the OxMaR computer system (acronym for Oxford Minimization and Randomization) was used. Each investigator will assign a code to each recruited patient that is recorded in the online randomization form, along with the type of fracture and the patient's sex, which are included as minimization variables.

Description of the intervention

Once the participants have been recruited for the study and have been randomly assigned to the experimental or control group, the surgical intervention will be carried out following the principles of usual clinical practice.

The patient will be operated by an orthopedic surgeon hospital following the usual protocol of the hospital and surgical technique. The implant used will be in all cases an intramedullary nail. Depending on whether the patient has been included in the experimental or control group, surgery will be performed by adding augmentation with polymethylmethacrylate cement to the cephalic component or not.

Regarding blinding, the patient will remain blind to the assignment to one group or another and only the surgeon and the researchers will know the group to which they have been assigned to, given that cement augmentation is easily identifiable for them in a standard radiological control taken during follow-up.

The rest of the follow-up will follow the usual clinical practice during hospital admission and subsequently on an outpatient basis, with controls in outpatient clinics at one month, three months, six months and one year post-intervention. A radiological control will be taken in all follow-ups. Both the clinical follow-up by the surgeon and the radiological follow-up are the same as those carried out in normal clinical practice for this type of pathology. No greater number of visits, consultations, complementary tests, procedures or additional participation are required from the patient for participating in the study.

Conditions

Hip Fracture of Intertrochanteric Type

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cemented

Patients diagnosed of pertrochanteric hip fracture treated with intramedullary nailing WITH cephalic augmentation using bone cement

Group Type: EXPERIMENTAL

intramedullary nailing augmentation

Intervention Type: DEVICE

Treatment of pertrochanteric hip fractures with intramedullary nailing with cephalic augmentation with bone cement

Not Cemented

Patients diagnosed of pertrochanteric hip fracture treated with intramedullary nailing WITHOUT cephalic augmentation

Group Type: ACTIVE_COMPARATOR

intramedullary nailing

Intervention Type: DEVICE

Treatment of pertrochanteric hip fractures with intramedullary nailing without cephalic augmentation

Interventions

intramedullary nailing augmentation

Treatment of pertrochanteric hip fractures with intramedullary nailing with cephalic augmentation with bone cement

Intervention Type: DEVICE

intramedullary nailing

Treatment of pertrochanteric hip fractures with intramedullary nailing without cephalic augmentation

Intervention Type: DEVICE

Other Intervention Names

Osteosynthesis; osteosynthesis

Eligibility Criteria

Inclusion Criteria

• 75 years of age or older.
• Diagnosis with a pertrochanteric fragility fracture.
• Informed consent for participation in the study.

• Refusal of the patient or his/her legal representative to participate in the study.
• Diagnosis with hip fracture of subtypes other than 31A1, 31A2, 31A3 and 31B3 of AO-OTA classification.
• Bilateral hip fractures in the same episode.
• Suffering from previous medical pathologies or comorbidities that contraindicate surgical intervention and indicate conservative management of the fracture.
• Performing a surgical technique different from intramedullary nailing or using a surgical implant different from that used in the present study.

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Diego Matías Domínguez Prado

OTHER

Sponsor Role: lead

Responsible Party

Diego Matías Domínguez Prado

Specialist in Orthopedic Surgery and Traumatology, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Diego Matias Dominguez Prado, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Complexo Hospitalario de Ourense

Locations

Hospital de Monforte de Lemos

Monforte de Lemos, Lugo, Spain

Site Status: RECRUITING

Hospital de Verin

Verín, Ourense, Spain

Site Status: RECRUITING

Complexo Hospitalario Universitario de Vigo

Vigo, Pontevedra, Spain

Site Status: RECRUITING

Hospital do Salnes

Vilagarcía de Arousa, Pontevedra, Spain

Site Status: RECRUITING

Complexo Hospitalario Universitario de Ourense

Ourense, , Spain

Site Status: RECRUITING

Complexo Hospitalario Pontevedra

Pontevedra, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Diego Matias Dominguez Prado, MD, PhD

Role: CONTACT

diego.matias.dominguez.prado@sergas.es

34+ 670462170

Facility Contacts

Lucia Ferradas Garcia, MD

Role: primary

lucia.ferradas.garcia@sergas.es

34+ 982417900

Sandra Iglesias Rodriguez, MD

Role: primary

sandra.iglesias.rodriguez@sergas.es

34+ 988413636

Miguel Cela Lopez, MD

Role: primary

miguel.cela.lopez@sergas.es

34+ 986811111

Maciej Denisiuk, MD

Role: primary

maciej.denisiuk@sergas.es

34+ 986568000

Diego Matias Dominguez Prado, MD, PhD

Role: primary

diego.matias.dominguez.prado@sergas.es

34+ 988385500

Alejandro Garcia Reza, MD

Role: primary

alejandro.garcia.reza@sergas.es

34+ 988385500

Other Identifiers

2024-235

Identifier Type: -

Identifier Source: org_study_id