Proximal Femoral FracturesNCT06200402
Antibiotic-Loaded Cement Versus Non-Antibiotic-Loaded Cement in Hip Prosthesis Surgery for Proximal Femur Fractures
A study testing Antibiotic loaded in people with Proximal Femoral Fractures, run by Università Vita-Salute San Raffaele at 1 site in Italy.
Trial summary
The study aims to determine if antibiotic-loaded cement reduces post-surgery infection rates compared to non-antibiotic cement. The trial involves 450 elderly patients with specific hip fractures, assessing infection incidence, implant stability, and associated costs. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Proximal Femoral Fractures
- What is being tested?
- Antibiotic loaded
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patients must be older than 65 years
- Fracture Type: The study includes patients with medial femoral neck fractures classified as AO type B1, B2, and B3, indicating specific types of hip fractures.
- Surgical Indication: Patients should have an indication for prosthetic hip surgery.
- Informed Consent: Patients must provide signed informed consent to participate in the study
Who cannot join
- Fracture Type: Exclusion of patients with trochanteric region fractures and femoral head fractures (AO classification types A and C), periprosthetic fractures, patients with multiple traumas or multiple fractures.
- Blood Test Anomalies: Patients with pre-operative blood test anomalies, such as ionic disorders and hemoglobin levels lower than 8 g/dL.
- Renal Insufficiency: Patients with renal insufficiency.
- Active Infections: Exclusion of patients with active infections or suspected/confirmed hypersensitivity or allergy to gentamicin, history of toxicity or reaction to aminoglycosides.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ircss Ospedale San Raffaele
Milan, Lombardy, 20149
Giacomo Placella, MD, +390226431, placella.giacomo@hsr.it
About this study
Official title: Antibiotic-Loaded Cement Versus Non-Antibiotic-Loaded Cement in Hip Prosthesis Surgery for Proximal Femur Fractures: A Prospective, Randomized, Single-Center, Blinded Study
The study aims to determine if antibiotic-loaded cement reduces post-surgery infection rates compared to non-antibiotic cement. The trial involves 450 elderly patients with specific hip fractures, assessing infection incidence, implant stability, and associated costs. This randomized, blinded study is conducted by IRCCS Ospedale San Raffaele.
- Conditions
- Proximal Femoral Fractures
- Being tested
- Antibiotic loaded, Placebo
- Medical subject headings
- Proximal Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic loadedDrug
This is the intervention for the study group. It involves the use of bone cement mixed with antibiotics (typically gentamicin or similar) in the hip prosthesis surgery. The purpose of this intervention is to assess whether the antibiotic-loaded cement reduces the incidence of postoperative infections compared to standard cement
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | (Antibiotic-Loaded Cement Arm): This group will receive hip prosthesis surgery using antibiotic-loaded cement. The use of antibiotic-loaded cement is intended to investigate its effectiveness in reducing the rate of acute postoperative infections. Receives: Drug: Antibiotic loaded |
| control | Placebo comparator | (Non-Antibiotic-Loaded Cement Arm): Participants in this group will undergo hip prosthesis surgery using non-antibiotic-loaded cement. This arm serves as the control to compare the outcomes with the antibiotic-loaded cement group. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Acute Postoperative Infections
This outcome measure focuses on the rate of acute infections occurring postoperatively in patients undergoing hip prosthesis surgery. The study will compare the incidence of such infections between the two groups: one receiving antibiotic-loaded cement and the other receiving non-antibiotic-loaded cement. An acute infection is typically defined based on clinical signs, laboratory markers of infection (like elevated C-reactive protein levels, white blood cell count, etc.), and the need for any additional interventions or treatments due to infection.
Measured: 7 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 Jul 2023
- Primary completion1 Dec 2023
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Femoral FracturesStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Giacomo Placella, Università Vita-Salute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200402
- Sponsor's protocol ID
- BCHIP
- Status last verified
- Dec 2023
- First submitted
- 27 Dec 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic-Loaded Cement Versus Non-Antibiotic-Loaded Cement in Hip Prosthesis Surgery for Proximal Femur Fractures: A Prospective, Randomized, Single-Center, Blinded Study
- ClinicalTrials.gov ID
- NCT06200402
- Acronym / sponsor ID
- BCHIP
- Conditions
- Proximal Femoral Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 11 Jan 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 study aims to determine if antibiotic-loaded cement reduces post-surgery infection rates compared to non-antibiotic cement. The trial involves 450 elderly patients with specific hip fractures, assessing infection incidence, implant stability, and associated costs. This randomized, blinded study is conducted by IRCCS Ospedale San Raffaele.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Antibiotic loaded(Antibiotic-Loaded Cement Arm): This group will receive hip prosthesis surgery using antibiotic-loaded cement. The use of antibiotic-loaded cement is intended to investigate its effectiveness in reducing the rate of acute postoperative infections. |
| control | Placebo comparator | Other: Placebo(Non-Antibiotic-Loaded Cement Arm): Participants in this group will undergo hip prosthesis surgery using non-antibiotic-loaded cement. This arm serves as the control to compare the outcomes with the antibiotic-loaded cement group. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients must be older than 65 years
- Fracture Type: The study includes patients with medial femoral neck fractures classified as AO type B1, B2, and B3, indicating specific types of hip fractures.
- Surgical Indication: Patients should have an indication for prosthetic hip surgery.
- Informed Consent: Patients must provide signed informed consent to participate in the study
Key exclusion criteria (4 listed)
- Fracture Type: Exclusion of patients with trochanteric region fractures and femoral head fractures (AO classification types A and C), periprosthetic fractures, patients with multiple traumas or multiple fractures.
- Blood Test Anomalies: Patients with pre-operative blood test anomalies, such as ionic disorders and hemoglobin levels lower than 8 g/dL.
- Renal Insufficiency: Patients with renal insufficiency.
- Active Infections: Exclusion of patients with active infections or suspected/confirmed hypersensitivity or allergy to gentamicin, history of toxicity or reaction to aminoglycosides.
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 |
|---|---|---|
| Antibiotic loadedThis is the intervention for the study group. It involves the use of bone cement mixed with antibiotics (typically gentamicin or similar) in the hip prosthesis surgery. The purpose of this intervention is to assess whether the antibiotic-loaded cement reduces the incidence of postoperative infections compared to standard cement | Drug | Intervention |
| PlaceboPlacebo | Other | control |
Primary outcome
Incidence of Acute Postoperative Infections
Time frame: 7 days post surgery
This outcome measure focuses on the rate of acute infections occurring postoperatively in patients undergoing hip prosthesis surgery. The study will compare the incidence of such infections between the two groups: one receiving antibiotic-loaded cement and the other receiving non-antibiotic-loaded cement. An acute infection is typically defined based on clinical signs, laboratory markers of infection (like elevated C-reactive protein levels, white blood cell count, etc.), and the need for any additional interventions or treatments due to infection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antibiotic loaded in people with Proximal Femoral Fractures, run by Università Vita-Salute San Raffaele at 1 site in Italy.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Acute Postoperative Infections (time frame: 7 days post surgery). 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 11 Jan 2024.