Prosthetic Joint InfectionPhase 4NCT04042233
Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol
A Phase 4 study testing Experimental Intraosseous vancomycin 500mg in 250 mL NS and Standard IV administration of vancomycin in people with Prosthetic Joint Infection and Vancomycin, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
The objective of this study is to evaluate a novel vancomycin intraosseous administration protocol vs a standard IV vancomycin administration protocol for primary total hip arthroplasty patients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Prosthetic Joint Infection, Vancomycin, Joint Diseases
- What is being tested?
- Experimental Intraosseous vancomycin 500mg in 250 mL NS and Standard IV administration of vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2019to 1 Sep 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is undergoing a primary total hip arthroplasty
- Patient gives informed consent to participate in the study.
- Age Range >18
Who cannot join
- Previous surgery on the hip (including hip scopes)
- BMI above 35
- Contraindication to receiving vancomycin or cefepime (allergy, medical issue, etc)
- Inability to locate the greater trochanter or administer the IO infusion
- Refusal to participate
- Diabetes
- Immunocompromised or immunosuppressed patients (HIV, Hep C, End stage renal disease, dialysis, transplant, chemo/radiation treatment in last 6 months, medications).
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to evaluate a novel vancomycin intraosseous administration protocol vs a standard IV vancomycin administration protocol for primary total hip arthroplasty patients.
Read the detailed description
Patients are randomized to one of two groups.
GROUP A - Will receive IV antibiotics (cefepime \& vancomycin) are started in pre-op approximately 1 hour prior to incision vancomycin dose weight-based at approximately 15mg/kg, generally 1000-1750mg in 500 milliliters (mL) normal saline (NS).
GROUP B - Will have IV cefepime started in pre-op within 1 hour of incision. Intraosseous (IO) administration of vancomycin (500mg in 250 milliliters NS) will be administered in the OR after sterile prep and draping has occurred. Injection will take place into the greater trochanter (within a pre-specified region).
Both Groups will be monitored during surgery and immediately post-operatively for adverse injection reactions (i.e. Red Man Syndrome). Both groups will otherwise follow identical post-operative protocols (including post-operative antibiotic administration).
TISSUE SAMPLES Five (5) tissue samples will be taken from each patient, 2 soft tissue samples and 3 bone samples will be taken throughout the course of the procedure.
One blood sample will be taken in both groups intraoperatively at the time of initiation of closure.
These samples will immediately be sent to a lab for analysis.
- Conditions
- Prosthetic Joint Infection, Vancomycin, Joint Diseases
- Being tested
- Experimental Intraosseous vancomycin 500mg in 250 mL NS, Standard IV administration of vancomycin
- Keywords
- total hip arthroplasty, vancomycin, intraosseous vancomycin
- Medical subject headings
- Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Intraosseous vancomycin 500mg in 250 mL NSDrug
500mg of Vancomycin in 250 mL of normal saline will be injected into a pre-specified region of the greater trochanter during primary total hip arthroplasty.
Standard IV administration of vancomycinDrug
IV antibiotics (cefepime \& vancomycin) are started in pre-op approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg, generally 1000-1750mg in 500 mL NS).
| Study group | Role | What they receive |
|---|---|---|
| IV administration of vancomycin | Active comparator | Standard IV vancomycin administration protocol. Receives: Drug: Standard IV administration of vancomycin |
| IO Vancomycin 500mg in 250 mL NS | Experimental | Experimental Intraosseous administration protocol. Receives: Drug: Experimental Intraosseous vancomycin 500mg in 250 mL NS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic Vancomycin Level - Start of Case
vancomycin blood level before the time of incision - typically taken approximately 10 minutes before incision.
Measured: approximately 10 minutes before incision
Systemic Vancomycin Level - End of Case
Measured: end of surgical case
Vancomycin Concentration of Pulvinar Soft Tissue
vancomycin concentration (ug/mL) of pulvinar soft tissue. Vancomycin tissue concentration measured by high performance liquid chromotagraphy.
Measured: intraoperative
Vancomycin Concentration of Intramedullary Bone
Vancomycin Concentration of Intramedullary Bone in units ug/mL. Vancomycin tissue concentration measured by high performance liquid chromotagraphy.
Measured: intraoperative
Secondary outcomes (6)
Soft Tissue Vancomycin Level - Start of Case
at start , soft tissue. Vancomycin tissue concentration (ug/mL) measured by high performance liquid chromatography.
Measured: at start of case within 15 minutes after incision
Femur Vancomycin Concentration Level
Intraoperative femur bone sample measured for vancomycin concentration (ug/mL). Vancomycin tissue concentration measured by high performance liquid chromatography.
Measured: intraoperative
Acetabulum Vancomycin Level
Intra-operative Acetabulum bone vancomycin concentrations (ug/mL) measured by high performance liquid chromatography.
Measured: intraoperative
30-Day Complications
Complications 30 days post surgery eg. infection.
Measured: From the administration of antibiotics perioperatively to 30 days post op.
90-Day Complications
Complications 90 days post surgery eg. infection
Measured: From the administration of antibiotics perioperatively to 90 days post op.
Soft Tissue Vancomycin Level - End of Case
soft tissue taken at end of case, right before wound closure is initiated. Vancomycin tissue concentration (ug/mL) measured by high performance liquid chromatography.
Measured: right before wound closure is initiated at the end of the case
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start31 Dec 2019
- Primary completion25 May 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prosthetic Joint InfectionStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terry Clyburn, The Methodist Hospital Research Institute
- Investigators
- Terry A Clyburn, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042233
- Sponsor's protocol ID
- Pro00022651
- Status last verified
- Mar 2025
- First submitted
- 30 Jul 2019
- Last updated
- 13 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol
- ClinicalTrials.gov ID
- NCT04042233
- Acronym / sponsor ID
- Pro00022651
- Conditions
- Prosthetic Joint Infection, Vancomycin, Joint Diseases
- Keywords
- total hip arthroplasty, vancomycin, intraosseous vancomycin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 31 Dec 2019 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 1 Aug 2019 (actual)
- Results
- Posted 13 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate a novel vancomycin intraosseous administration protocol vs a standard IV vancomycin administration protocol for primary total hip arthroplasty patients.
Detailed description
Patients are randomized to one of two groups.
GROUP A - Will receive IV antibiotics (cefepime \& vancomycin) are started in pre-op approximately 1 hour prior to incision vancomycin dose weight-based at approximately 15mg/kg, generally 1000-1750mg in 500 milliliters (mL) normal saline (NS).
GROUP B - Will have IV cefepime started in pre-op within 1 hour of incision. Intraosseous (IO) administration of vancomycin (500mg in 250 milliliters NS) will be administered in the OR after sterile prep and draping has occurred. Injection will take place into the greater trochanter (within a pre-specified region).
Both Groups will be monitored during surgery and immediately post-operatively for adverse injection reactions (i.e. Red Man Syndrome). Both groups will otherwise follow identical post-operative protocols (including post-operative antibiotic administration).
TISSUE SAMPLES Five (5) tissue samples will be taken from each patient, 2 soft tissue samples and 3 bone samples will be taken throughout the course of the procedure.
One blood sample will be taken in both groups intraoperatively at the time of initiation of closure.
These samples will immediately be sent to a lab for analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV administration of vancomycin | Active comparator | Drug: Standard IV administration of vancomycinStandard IV vancomycin administration protocol. |
| IO Vancomycin 500mg in 250 mL NS | Experimental | Drug: Experimental Intraosseous vancomycin 500mg in 250 mL NSExperimental Intraosseous administration protocol. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is undergoing a primary total hip arthroplasty
- Patient gives informed consent to participate in the study.
- Age Range >18
Key exclusion criteria (7 listed)
- Previous surgery on the hip (including hip scopes)
- BMI above 35
- Contraindication to receiving vancomycin or cefepime (allergy, medical issue, etc)
- Inability to locate the greater trochanter or administer the IO infusion
- Refusal to participate
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 |
|---|---|---|
| Experimental Intraosseous vancomycin 500mg in 250 mL NS500mg of Vancomycin in 250 mL of normal saline will be injected into a pre-specified region of the greater trochanter during primary total hip arthroplasty. | Drug | IO Vancomycin 500mg in 250 mL NS |
| Standard IV administration of vancomycinIV antibiotics (cefepime \& vancomycin) are started in pre-op approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg, generally 1000-1750mg in 500 mL NS). | Drug | IV administration of vancomycin |
Primary outcome
Systemic Vancomycin Level - Start of Case
Time frame: approximately 10 minutes before incision
vancomycin blood level before the time of incision - typically taken approximately 10 minutes before incision.
Systemic Vancomycin Level - End of Case
Time frame: end of surgical case
Vancomycin Concentration of Pulvinar Soft Tissue
Time frame: intraoperative
vancomycin concentration (ug/mL) of pulvinar soft tissue. Vancomycin tissue concentration measured by high performance liquid chromotagraphy.
Vancomycin Concentration of Intramedullary Bone
Time frame: intraoperative
Vancomycin Concentration of Intramedullary Bone in units ug/mL. Vancomycin tissue concentration measured by high performance liquid chromotagraphy.
6 secondary outcomes
Soft Tissue Vancomycin Level - Start of Case
Time frame: at start of case within 15 minutes after incision
Femur Vancomycin Concentration Level
Time frame: intraoperative
Acetabulum Vancomycin Level
Time frame: intraoperative
30-Day Complications
Time frame: From the administration of antibiotics perioperatively to 30 days post op.
90-Day Complications
Time frame: From the administration of antibiotics perioperatively to 90 days post op.
Soft Tissue Vancomycin Level - End of Case
Time frame: right before wound closure is initiated at the end of the case
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Terry A Clyburn, MD principal investigator
The Methodist Hospital Research Institute
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 Experimental Intraosseous vancomycin 500mg in 250 mL NS and Standard IV administration of vancomycin in people with Prosthetic Joint Infection and Vancomycin, run by The Methodist Hospital Research Institute 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 7 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: finished, as of the sponsor's last update on 13 Mar 2025. 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. 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?
Yes. Results are posted in the registry (first posted 13 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Systemic Vancomycin Level - Start of Case (time frame: approximately 10 minutes before incision). The study lists 4 primary outcomes in all. 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 13 Mar 2025.