Knee OsteoarthritisNCT05338021
Intrawound Administration of Vancomycin in TKA
A study testing Intrawound administration of vancomycin after closure of the arthrotomy in people with Knee Osteoarthritis, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
The purpose of this study is to determine the intra-articular and serum levels of vancomycin over the first 24 hours postoperatively after intra-articular administration of a standard dose of vancomycin in primary total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Intrawound administration of vancomycin after closure of the arthrotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2022to 7 Sep 2022
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 50 and 80
- Total knee arthroplasty for primary osteoarthritis. Primary diagnosis of knee osteoarthritis
Who cannot join
- Diminished mental capacity
- Vancomycin allergy
- Chronic kidney disease stage III and stage IV
Trial locations and contacts
1 site in 1 country.
China1 site
The affiliated hospital of Qingdao University
Qingdao, Shandong, 266000
About this study
Official title: Serum and Wound Vancomycin Levels Following Intrawound Administration in Primary Total Knee Arthroplasty
The purpose of this study is to determine the intra-articular and serum levels of vancomycin over the first 24 hours postoperatively after intra-articular administration of a standard dose of vancomycin in primary total knee arthroplasty.
- Conditions
- Knee Osteoarthritis
- Being tested
- Intrawound administration of vancomycin after closure of the arthrotomy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrawound administration of vancomycin after closure of the arthrotomyProcedure or surgery
After closure of the arthrotomy, 1 g of vancomycin powder suspended in 30ml of normal saline was injected directly into the joint with an 18-gauge needle.
| Study group | Role | What they receive |
|---|---|---|
| Intrawound Administration of Vancomycin | Experimental | After closure of the arthrotomy, 1 g of vancomycin powder suspended in 30ml of normal saline was injected directly into the joint with an 18-gauge needle. Then 20ml of normal saline was injected directly into the joint. Receives: Procedure: Intrawound administration of vancomycin after closure of the arthrotomy |
| Intrawound Administration of Vancomycin combined with epsilon-aminocaproic acid (EACA) | Experimental | After closure of the arthrotomy, 1 g of vancomycin powder suspended in 30ml of normal saline was injected directly into the joint with an 18-gauge needle. Then 4g (20ml) of epsilon-aminocaproic acid (EACA) was injected directly into the joint. Receives: Procedure: Intrawound administration of vancomycin after closure of the arthrotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-articular vancomycin concentration
Measured: 2 hours, 8 hours and 24 hours postoperatively
Serum vancomycin concentration
Measured: 2 hours, 8 hours and 24 hours postoperatively
Renal function
blood urea nitrogen (BUN), creatinine (Cr), GFR
Measured: Postoperative Day 1 and Day 3
Blood loss
Measured: Postoperative Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start25 May 2022
- Primary completion7 Sep 2022
- Study completion7 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang Shuai, MD, The Affiliated Hospital of Qingdao University
- Investigators
- Shuai Xiang, M.D., Principal investigator, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338021
- Sponsor's protocol ID
- AHQingdao VancoTKA
- Status last verified
- Jan 2023
- First submitted
- 11 Apr 2022
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Li X, Lai J, Yang X, Xu H, Xiang S. Intra-articular injection of vancomycin after arthrotomy closure following gentamicin-impregnated bone cementation in primary total knee arthroplasty provides a high intra-articular concentration while avoiding systemic toxicity: a prospective study. J Orthop Surg Res. 2024 Dec 19;19(1):856. doi: 10.1186/s13018-024-05357-9.
PubMed 39702402
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum and Wound Vancomycin Levels Following Intrawound Administration in Primary Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05338021
- Acronym / sponsor ID
- AHQingdao VancoTKA
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 7 Sep 2022 (actual)
- Study completion
- 7 Sep 2022 (actual)
- First posted
- 20 Apr 2022 (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 purpose of this study is to determine the intra-articular and serum levels of vancomycin over the first 24 hours postoperatively after intra-articular administration of a standard dose of vancomycin in primary total knee arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrawound Administration of Vancomycin | Experimental | Procedure: Intrawound administration of vancomycin after closure of the arthrotomyAfter closure of the arthrotomy, 1 g of vancomycin powder suspended in 30ml of normal saline was injected directly into the joint with an 18-gauge needle. Then 20ml of normal saline was injected directly into the joint. |
| Intrawound Administration of Vancomycin combined with epsilon-aminocaproic acid (EACA) | Experimental | Procedure: Intrawound administration of vancomycin after closure of the arthrotomyAfter closure of the arthrotomy, 1 g of vancomycin powder suspended in 30ml of normal saline was injected directly into the joint with an 18-gauge needle. Then 4g (20ml) of epsilon-aminocaproic acid (EACA) was injected directly into the joint. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 50 and 80
- Total knee arthroplasty for primary osteoarthritis. Primary diagnosis of knee osteoarthritis
Key exclusion criteria (3 listed)
- Diminished mental capacity
- Vancomycin allergy
- Chronic kidney disease stage III and stage IV
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 |
|---|---|---|
| Intrawound administration of vancomycin after closure of the arthrotomyAfter closure of the arthrotomy, 1 g of vancomycin powder suspended in 30ml of normal saline was injected directly into the joint with an 18-gauge needle. | Procedure or surgery | Intrawound Administration of Vancomycin, Intrawound Administration of Vancomycin combined with epsilon-aminocaproic acid (EACA) |
Primary outcome
Intra-articular vancomycin concentration
Time frame: 2 hours, 8 hours and 24 hours postoperatively
Serum vancomycin concentration
Time frame: 2 hours, 8 hours and 24 hours postoperatively
Renal function
Time frame: Postoperative Day 1 and Day 3
blood urea nitrogen (BUN), creatinine (Cr), GFR
Blood loss
Time frame: Postoperative Day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Derived from this study: PubMed 39702402Li X, Lai J, Yang X, Xu H, Xiang S. Intra-articular injection of vancomycin after arthrotomy closure following gentamicin-impregnated bone cementation in primary total knee arthroplasty provides a high intra-articular concentration while avoiding systemic toxicity: a prospective study. J Orthop Surg Res. 2024 Dec 19;19(1):856. doi: 10.1186/s13018-024-05357-9.
- Individual participant dataSharing planned: Yes
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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.
Shuai Xiang, M.D. principal investigator
The Affiliated Hospital of Qingdao University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrawound administration of vancomycin after closure of the arthrotomy in people with Knee Osteoarthritis, run by The Affiliated Hospital of Qingdao University at 1 site in China.
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 2 inclusion and 3 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 19 Jan 2023. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intra-articular vancomycin concentration (time frame: 2 hours, 8 hours and 24 hours postoperatively). 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?
On the ClinicalTrials.gov record for NCT05338021, which also lists 1 linked publication.
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 19 Jan 2023.