Hip Fracture of Intertrochanteric TypeHipOsGalNCT06634290
Influence of Cemented Cephalic Augmentation on the Outcome of Intramedullary Nailing in Pertrochanteric Hip Fractures
A study testing intramedullary nailing augmentation and intramedullary nailing in people with Hip Fracture of Intertrochanteric Type, run by Diego Matías Domínguez Prado at 6 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Hip Fracture of Intertrochanteric Type
- What is being tested?
- intramedullary nailing augmentation and intramedullary nailing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 6 sitesSpain
- Study dates
- 30 Sep 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 75 years of age or older.
- Diagnosis with a pertrochanteric fragility fracture.
- Informed consent for participation in the study.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Spain6 sites, 6 recruiting
- Recruiting
Hospital de Monforte de Lemos
Monforte de Lemos, Lugo, 27400
Lucia Ferradas Garcia, MD, 34+ 982417900, lucia.ferradas.garcia@sergas.es
Lucia Ferradas Garcia, MD
- Recruiting
Complexo Hospitalario Universitario de Ourense
Ourense, 32005
Diego Matias Dominguez Prado, MD, PhD, 34+ 988385500, diego.matias.dominguez.prado@sergas.es
Diego Matias Dominguez Prado, MD, PhD
- Recruiting
Complexo Hospitalario Pontevedra
Pontevedra, 36071
Alejandro Garcia Reza, MD, 34+ 988385500, alejandro.garcia.reza@sergas.es
Alejandro Garcia Reza, MD
- Recruiting
Hospital de Verin
Verín, Ourense, 32600
Sandra Iglesias Rodriguez, MD, 34+ 988413636, sandra.iglesias.rodriguez@sergas.es
Sandra Iglesias Rodriguez, MD
- Recruiting
Complexo Hospitalario Universitario de Vigo
Vigo, Pontevedra, 36312
Miguel Cela Lopez, MD, 34+ 986811111, miguel.cela.lopez@sergas.es
Miguel Cela Lopez, MD
- Recruiting
Hospital do Salnes
Vilagarcía de Arousa, Pontevedra, 36619
Maciej Denisiuk, MD, 34+ 986568000, maciej.denisiuk@sergas.es
Maciej Denisiuk, MD
About this study
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
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:
Read more
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.
Read the 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
- Being tested
- intramedullary nailing augmentation, intramedullary nailing
- Keywords
- hip fracture, osteosynthesis, intramedullary nailing, bone cement augmentation
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intramedullary nailing augmentationDevice
Also called Osteosynthesis
Treatment of pertrochanteric hip fractures with intramedullary nailing with cephalic augmentation with bone cement
intramedullary nailingDevice
Also called osteosynthesis
Treatment of pertrochanteric hip fractures with intramedullary nailing without cephalic augmentation
| Study group | Role | What they receive |
|---|---|---|
| Cemented | Experimental | Patients diagnosed of pertrochanteric hip fracture treated with intramedullary nailing WITH cephalic augmentation using bone cement Receives: Device: intramedullary nailing augmentation |
| Not Cemented | Active comparator | Patients diagnosed of pertrochanteric hip fracture treated with intramedullary nailing WITHOUT cephalic augmentation Receives: Device: intramedullary nailing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical failure rate of the implant
Defined as the intolerable loss of reduction of the fracture and the failure of osteosynthesis due to breakage or disassembly of the implant used, which requires surgical reintervention.
Measured: From date of surgery until the date of mechanical failure diagnosis, assessed up to 52 weeks
Secondary outcomes (3)
Perioperative mortality rate
Proportion of participants who die compared to the total participants during hospital stay, assessed up to a maximum of 7 days
Measured: From date of surgery until the date of hospital discharge, assessed up to a maximum of 7 days
One-month mortality rate
Proportion of participants who die compared to the total participants during a period of 30 days
Measured: From date of surgery up to 30 days
One-year mortality rate
Proportion of participants who die compared to the total participants during a period of 52 weeks
Measured: From date of surgery up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start30 Sep 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Fracture of Intertrochanteric TypeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diego Matías Domínguez Prado
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Diego Matías Domínguez Prado, Fundacin Biomedica Galicia Sur
- Investigators
- Diego Matias Dominguez Prado, MD, PhD, Principal investigator, Complexo Hospitalario de Ourense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634290
- Sponsor's protocol ID
- 2024-235
- Acronym
- HipOsGal
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2024
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All collected IPD. Anonymized.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06634290
- Acronym / sponsor ID
- HipOsGal / 2024-235
- Conditions
- Hip Fracture of Intertrochanteric Type
- Keywords
- hip fracture, osteosynthesis, intramedullary nailing, bone cement augmentation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- Diego Matías Domínguez PradoUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cemented | Experimental | Device: intramedullary nailing augmentationPatients diagnosed of pertrochanteric hip fracture treated with intramedullary nailing WITH cephalic augmentation using bone cement |
| Not Cemented | Active comparator | Device: intramedullary nailingPatients diagnosed of pertrochanteric hip fracture treated with intramedullary nailing WITHOUT cephalic augmentation |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 75 years of age or older.
- Diagnosis with a pertrochanteric fragility fracture.
- Informed consent for participation in the study.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intramedullary nailing augmentationAlso: OsteosynthesisTreatment of pertrochanteric hip fractures with intramedullary nailing with cephalic augmentation with bone cement | Device | Cemented |
| intramedullary nailingAlso: osteosynthesisTreatment of pertrochanteric hip fractures with intramedullary nailing without cephalic augmentation | Device | Not Cemented |
Primary outcome
Mechanical failure rate of the implant
Time frame: From date of surgery until the date of mechanical failure diagnosis, assessed up to 52 weeks
Defined as the intolerable loss of reduction of the fracture and the failure of osteosynthesis due to breakage or disassembly of the implant used, which requires surgical reintervention.
3 secondary outcomes
Perioperative mortality rate
Time frame: From date of surgery until the date of hospital discharge, assessed up to a maximum of 7 days
One-month mortality rate
Time frame: From date of surgery up to 30 days
One-year mortality rate
Time frame: From date of surgery up to 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Yes. All collected IPD. Anonymized.
Related trials for Hip Fracture of Intertrochanteric Type
Active, not recruiting
Diffrence in Thromboprofilaksis in Elderly Ostoepenic Hip Fractures According to Mobility Status by Genetic Analysis
Hip Fracture of Intertrochanteric Type, Thromboembolic Event
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Diego Matias Dominguez Prado, MD, PhD principal investigator
Complexo Hospitalario de Ourense
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intramedullary nailing augmentation and intramedullary nailing in people with Hip Fracture of Intertrochanteric Type, run by Diego Matías Domínguez Prado at 6 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diego Matias Dominguez Prado, MD, PhD (34+ 670462170, diego.matias.dominguez.prado@sergas.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanical failure rate of the implant (time frame: From date of surgery until the date of mechanical failure diagnosis, assessed up to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.