Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634290
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
Influence of Cemented Cephalic Augmentation on the Outcome of Intramedullary Nailing in Pertrochanteric Hip Fractures
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HipOsGal
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
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 andor 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 patients 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
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 andor 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None