Clinical trial NCT06634290: Influence of Cemented Cephalic Augmentation on the Outcome of Intramedullary Nailing in Pertrochanteric Hip Fractures
Official title: Influence of Cemented Cephalic Augmentation on the Outcome of Osteosynthesis Using Intramedullary Nailing in the Surgical Treatment of Pertrochanteric Hip Fractures in the Elderly
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Fracture of Intertrochanteric Type
Keywords: hip fracture
osteosynthesis
intramedullary nailing
bone cement augmentation
Lead sponsor: Fundacin Biomedica Galicia Sur
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 314
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Not meeting the inclusion criteria described above.
* 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.

Primary outcomes:
measure: Mechanical failure rate of the implant
timeFrame: From date of surgery until the date of mechanical failure diagnosis, assessed up to 52 weeks
Secondary outcomes:
measure: Perioperative mortality rate
timeFrame: From date of surgery until the date of hospital discharge, assessed up to a maximum of 7 days
measure: One-month mortality rate
timeFrame: From date of surgery up to 30 days
measure: One-year mortality rate
timeFrame: From date of surgery up to 52 weeks
Other outcomes:
Locations:
city: Monforte de Lemos
country: Spain
facility: Hospital de Monforte de Lemos
state: Lugo
city: Verín
country: Spain
facility: Hospital de Verin
state: Ourense
city: Vigo
country: Spain
facility: Complexo Hospitalario Universitario de Vigo
state: Pontevedra
city: Vilagarcia de Arousa
country: Spain
facility: Hospital do Salnes
state: Pontevedra
city: Ourense
country: Spain
facility: Complexo Hospitalario Universitario de Ourense
city: Pontevedra
country: Spain
facility: Complexo Hospitalario Pontevedra
Study officials:
affiliation: Complexo Hospitalario de Ourense
name: Diego Matias Dominguez Prado, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: