Antibiotic Prophylaxis SurgeryPhase 4NCT07549542
Efficacy and Safety of Intraosseous Antibiotic Prophylaxis in Total Hip Replacement
A Phase 4 study testing CeFAZolin 1000 MG and Saline (0.9%, sterile, for infusion) in people with Antibiotic Prophylaxis Surgery, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if intraosseous antibiotic (cefazolin) administration can improve antibiotic levels in adults undergoing primary total hip replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antibiotic Prophylaxis Surgery
- What is being tested?
- CeFAZolin 1000 MG and Saline (0.9%, sterile, for infusion)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2025to Nov 2026
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Scheduled to undergo primary total hip arthroplasty
- Receiving standard institutional antibiotic prophylaxis with IV bolus cefazolin prior to surgery
Who cannot join
- Reduced renal function (GFR < 30)
- Reduced liver function (AST/ALT > 3× upper limit of normal)
- Weight > 120 kg
- Undergoing bilateral total hip arthroplasty
- Documented cefazolin anaphylaxis
- Active joint infection
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- History of diabetes
- Inflammatory arthropathies
- Inability to understand written and/or spoken English
- Undergoing revision total hip arthroplasty
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Robert Wood Johnson University Hospital Somerset
Somerset, New Jersey, 08876
About this study
Official title: Efficacy and Safety of Intraosseous Antibiotic Prophylaxis in Total Hip Replacement: A Prospective Randomized Controlled Trial
The goal of this clinical trial is to learn if intraosseous antibiotic (cefazolin) administration can improve antibiotic levels in adults undergoing primary total hip replacement. The main question it aims to answer is:
- Does intraosseous cefazolin increase antibiotic concentrations in blood and tissue compared with standard intravenous cefazolin alone? Researchers will compare patients receiving intraosseous cefazolin plus standard intravenous cefazolin to those receiving placebo injection plus standard intravenous cefazolin to see if local antibiotic delivery improves outcomes.
Read more
Participants will:
- Receive standard intravenous cefazolin before surgery and either intraosseous cefazolin or placebo
- Provide blood samples before and after antibiotic administration
- Have small tissue samples collected during surgery
- Complete routine postoperative follow-up and outcome assessment for 90 days
- Conditions
- Antibiotic Prophylaxis Surgery
- Being tested
- CeFAZolin 1000 MG, Saline (0.9%, sterile, for infusion)
- Keywords
- Antibiotic prophylaxis, intraosseous antibiotics, intraosseous ancef
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeFAZolin 1000 MGDrug
1 gram of ancef will be administered intra-osseously into the patient's operative side greater trochanter
Saline (0.9%, sterile, for infusion)Drug
normal saline
| Study group | Role | What they receive |
|---|---|---|
| Intraosseous Ancef | Experimental | 50cc mixture of sterile injectable normal saline and one gram of ancef will be administered intra-osseously into the patient's operative side greater trochanter prior to incision Receives: Drug: CeFAZolin 1000 MG; Drug: Saline (0.9%, sterile, for infusion) |
| Intraosseous Saline | Placebo comparator | 50cc sterile injectable normal saline will be administered intra-osseously into the patient's operative side greater trochanter prior to incision Receives: Drug: Saline (0.9%, sterile, for infusion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cefazolin Concentration
Cefazolin concentration in local tissues and serum
Measured: From administration of intra-osseous ancef to 4 hours post-operatively
Secondary outcomes (1)
Post-operative complications
Any post-operative complications, potentially related to the intra-osseous ancef or otherwise
Measured: time of surgery to 90 days from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start20 Oct 2025
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Antibiotic Prophylaxis SurgeryStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial with intraosseous ancef group and placebo (saline) group with goal of determining antibiotic concentrations in local tissues and serum
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrezj Brzezinski, MD, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549542
- Sponsor's protocol ID
- PRO2026000363
- Other IDs
- PC 110-25, IRB00004311
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang J, Chen G, Yu X, Liu Y, Li Z, Zhang X, Zhong Q, Xu R. Higher cefazolin concentrations in synovial fluid with intraosseous regional prophylaxis in knee arthroplasty: a randomized controlled trial. Arch Orthop Trauma Surg. 2024 Sep;144(9):4069-4075. doi: 10.1007/s00402-023-05108-1. Epub 2023 Oct 30.
PubMed 37902891Young SW, Zhang M, Freeman JT, Vince KG, Coleman B. Higher cefazolin concentrations with intraosseous regional prophylaxis in TKA. Clin Orthop Relat Res. 2013 Jan;471(1):244-9. doi: 10.1007/s11999-012-2469-2.
PubMed 22773397Harper KD, Park KJ, Brozovich AA, Sullivan TC, Serpelloni S, Taraballi F, Incavo SJ, Clyburn TA. Otto Aufranc Award: Intraosseous Vancomycin in Total Hip Arthroplasty - Superior Tissue Concentrations and Improved Efficiency. J Arthroplasty. 2023 Jul;38(7S):S11-S15. doi: 10.1016/j.arth.2023.04.028. Epub 2023 Apr 23.
PubMed 37088221
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Intraosseous Antibiotic Prophylaxis in Total Hip Replacement: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07549542
- Acronym / sponsor ID
- PRO2026000363
- Conditions
- Antibiotic Prophylaxis Surgery
- Keywords
- Antibiotic prophylaxis, intraosseous antibiotics, intraosseous ancef
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 24 Apr 2026 (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 intraosseous antibiotic (cefazolin) administration can improve antibiotic levels in adults undergoing primary total hip replacement. The main question it aims to answer is:
- Does intraosseous cefazolin increase antibiotic concentrations in blood and tissue compared with standard intravenous cefazolin alone? Researchers will compare patients receiving intraosseous cefazolin plus standard intravenous cefazolin to those receiving placebo injection plus standard intravenous cefazolin to see if local antibiotic delivery improves outcomes.
Participants will:
- Receive standard intravenous cefazolin before surgery and either intraosseous cefazolin or placebo
- Provide blood samples before and after antibiotic administration
- Have small tissue samples collected during surgery
- Complete routine postoperative follow-up and outcome assessment for 90 days
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized control trial with intraosseous ancef group and placebo (saline) group with goal of determining antibiotic concentrations in local tissues and serum
| Arm | Type | Receives |
|---|---|---|
| Intraosseous Ancef | Experimental | Drug: CeFAZolin 1000 MG, Drug: Saline (0.9%, sterile, for infusion)50cc mixture of sterile injectable normal saline and one gram of ancef will be administered intra-osseously into the patient's operative side greater trochanter prior to incision |
| Intraosseous Saline | Placebo comparator | Drug: Saline (0.9%, sterile, for infusion)50cc sterile injectable normal saline will be administered intra-osseously into the patient's operative side greater trochanter prior to incision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Scheduled to undergo primary total hip arthroplasty
- Receiving standard institutional antibiotic prophylaxis with IV bolus cefazolin prior to surgery
Key exclusion criteria (10 listed)
- Reduced renal function (GFR < 30)
- Reduced liver function (AST/ALT > 3× upper limit of normal)
- Weight > 120 kg
- Undergoing bilateral total hip arthroplasty
- Documented cefazolin anaphylaxis
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 |
|---|---|---|
| CeFAZolin 1000 MG1 gram of ancef will be administered intra-osseously into the patient's operative side greater trochanter | Drug | Intraosseous Ancef |
| Saline (0.9%, sterile, for infusion)normal saline | Drug | Intraosseous Ancef, Intraosseous Saline |
Primary outcome
Cefazolin Concentration
Time frame: From administration of intra-osseous ancef to 4 hours post-operatively
Cefazolin concentration in local tissues and serum
1 secondary outcome
Post-operative complications
Time frame: time of surgery to 90 days from surgery
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 29 Apr 2026.
- Background: PubMed 37902891Zhang J, Chen G, Yu X, Liu Y, Li Z, Zhang X, Zhong Q, Xu R. Higher cefazolin concentrations in synovial fluid with intraosseous regional prophylaxis in knee arthroplasty: a randomized controlled trial. Arch Orthop Trauma Surg. 2024 Sep;144(9):4069-4075. doi: 10.1007/s00402-023-05108-1. Epub 2023 Oct 30.
- Background: PubMed 22773397Young SW, Zhang M, Freeman JT, Vince KG, Coleman B. Higher cefazolin concentrations with intraosseous regional prophylaxis in TKA. Clin Orthop Relat Res. 2013 Jan;471(1):244-9. doi: 10.1007/s11999-012-2469-2.
- Background: PubMed 37088221Harper KD, Park KJ, Brozovich AA, Sullivan TC, Serpelloni S, Taraballi F, Incavo SJ, Clyburn TA. Otto Aufranc Award: Intraosseous Vancomycin in Total Hip Arthroplasty - Superior Tissue Concentrations and Improved Efficiency. J Arthroplasty. 2023 Jul;38(7S):S11-S15. doi: 10.1016/j.arth.2023.04.028. Epub 2023 Apr 23.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CeFAZolin 1000 MG and Saline (0.9%, sterile, for infusion) in people with Antibiotic Prophylaxis Surgery, run by Rutgers, The State University of New Jersey at 1 site in United States.
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 10 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: enrolling by invitation, as of the sponsor's last update on 29 Apr 2026. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cefazolin Concentration (time frame: From administration of intra-osseous ancef to 4 hours post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07549542, which also lists 3 linked publications.
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 29 Apr 2026.