InfectionTKA_VancoNCT05461651
Infection Prevention After TKA With or Without Vancomycin
A study testing Knee arthroplasty in people with Infection, run by Centre of Postgraduate Medical Education at 1 site in Poland.
Trial summary
Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes in prevention of infection after Total Knee Arthroplasty With or Without Vancomycin. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infection
- What is being tested?
- Knee arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,800 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2021to 1 Jan 2029
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gosnartrosis
Who cannot join
- no informed consent to participate in the study age under 40 multilligament injury or single plane knee instability another musculoskeletal disorders in lower limb ASA score > II
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Department of Orthopaedics and Traumatology, Postgraduate Center for Medical Education, Professor A. Gruca Teaching Hospital
Otwock, Masovian Voivodeship, 05-400
Rafal Kaminski, MD PhD, +48227794031 ext. 469, rkaminski@spskgruca.pl
Stanislaw Pomianowski, MD PhD Prof, +48227794031 ext. 481, spom@spskgruca.pl
About this study
Official title: Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes in Prevention of Infection After Total Knee Arthroplasty With or Without Vancomycin.
Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes in prevention of infection after Total Knee Arthroplasty With or Without Vancomycin.
Read the detailed description
Infection after surgery is one of the most common complication after total knee replacement. Our prospective randomized study is intended to show if addition of vancomycin to the joint before the wound closure will decrease infection after operation.
- Conditions
- Infection
- Being tested
- Knee arthroplasty
- Keywords
- TKA, Vancomycin
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee arthroplastyProcedure or surgery
total or unilateral knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Knee arthroplasty | Sham comparator | Knee arthroplasty without addition of antibiotic wash oraz antibitiotic powder to the surgery site Receives: Procedure: Knee arthroplasty |
| Knee arthroplasty + vancomycin | Active comparator | Knee arthroplasty with addition of vancomysin powder to the surgery site Receives: Procedure: Knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of surgical site infection
The incidence of deep and superficial SSI after knee arthroplasty
Measured: up to 24 months
Secondary outcomes (22)
Blood test - CRP
inflammatory reaction - CRP
Measured: 12 weeks,
Blood test - IL 6
inflammatory reaction - Il-6
Measured: 12 weeks,
Functional tests
hop-for-distance
Measured: 12 weeks,
Functional tests
hop-for-distance
Measured: 6 months,
Functional tests
hop-for-distance
Measured: 12 months
Functional tests
hop-for-distance
Measured: 24 months
Knee injury and Osteoarthritis Outcome Score
Knee Injury and Osteoarthritis Outcome Score; KOOS is intended to be used for knee injury that can result in post traumatic osteoarthritis (OA); KOOS has high test-retest reliability. In patients with knee injury, ICCs for the Pain subscale range from 0.85-0.93, the Symptoms subscale from 0.83-0.95, the ADL subscale from 0.75-0.91, the Sport/Rec subscale from 0.61-0.89 and the QOL subscale from 0.83-0.95. In patients with knee OA, ICCs for the Pain subscale range from 0.8-0.97, the Symptoms subscale from 0.74-0.94, the ADL subscale from 0.84-0.94, the Sport/Rec subscale from 0.65-0.92 and the QOL subscale from 0.6-0.91 (4).
Measured: 6 weeks
Knee injury and Osteoarthritis Outcome Score
Knee Injury and Osteoarthritis Outcome Score; KOOS is intended to be used for knee injury that can result in post traumatic osteoarthritis (OA); KOOS has high test-retest reliability. In patients with knee injury, ICCs for the Pain subscale range from 0.85-0.93, the Symptoms subscale from 0.83-0.95, the ADL subscale from 0.75-0.91, the Sport/Rec subscale from 0.61-0.89 and the QOL subscale from 0.83-0.95. In patients with knee OA, ICCs for the Pain subscale range from 0.8-0.97, the Symptoms subscale from 0.74-0.94, the ADL subscale from 0.84-0.94, the Sport/Rec subscale from 0.65-0.92 and the QOL subscale from 0.6-0.91 (4).
Measured: 6 months
Knee injury and Osteoarthritis Outcome Score
Knee Injury and Osteoarthritis Outcome Score; KOOS is intended to be used for knee injury that can result in post traumatic osteoarthritis (OA); KOOS has high test-retest reliability. In patients with knee injury, ICCs for the Pain subscale range from 0.85-0.93, the Symptoms subscale from 0.83-0.95, the ADL subscale from 0.75-0.91, the Sport/Rec subscale from 0.61-0.89 and the QOL subscale from 0.83-0.95. In patients with knee OA, ICCs for the Pain subscale range from 0.8-0.97, the Symptoms subscale from 0.74-0.94, the ADL subscale from 0.84-0.94, the Sport/Rec subscale from 0.65-0.92 and the QOL subscale from 0.6-0.91 (4).
Measured: 12 months
Knee injury and Osteoarthritis Outcome Score
Knee Injury and Osteoarthritis Outcome Score; KOOS is intended to be used for knee injury that can result in post traumatic osteoarthritis (OA); KOOS has high test-retest reliability. In patients with knee injury, ICCs for the Pain subscale range from 0.85-0.93, the Symptoms subscale from 0.83-0.95, the ADL subscale from 0.75-0.91, the Sport/Rec subscale from 0.61-0.89 and the QOL subscale from 0.83-0.95. In patients with knee OA, ICCs for the Pain subscale range from 0.8-0.97, the Symptoms subscale from 0.74-0.94, the ADL subscale from 0.84-0.94, the Sport/Rec subscale from 0.65-0.92 and the QOL subscale from 0.6-0.91 (4).
Measured: 24 months
36-Item Short Form Survey
Quality of life, pain SF-36
Measured: 6 weeks
36-Item Short Form Survey
Quality of life, pain SF-36
Measured: 6 months
36-Item Short Form Survey
Quality of life, pain SF-36
Measured: 12 months
36-Item Short Form Survey
Quality of life, pain SF-36
Measured: 24 months
Visual analog Scale
Pain Visual Analog Scale
The pain VAS is a unidimensional measure of pain intensity. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health)[8] orientated from the left (worst) to the right (best).
Measured: 6 weeks
Visual analog Scale
Pain Visual Analog Scale
The pain VAS is a unidimensional measure of pain intensity. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health)[8] orientated from the left (worst) to the right (best).
Measured: 6 months
Visual analog Scale
Pain Visual Analog Scale
The pain VAS is a unidimensional measure of pain intensity. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health)[8] orientated from the left (worst) to the right (best).
Measured: 12 months
Visual analog Scale
Pain Visual Analog Scale
The pain VAS is a unidimensional measure of pain intensity. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health)[8] orientated from the left (worst) to the right (best).
Measured: 24 months
Tegner Lysholm Knee Scoring Scale
The Lysholm Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability).
Measured: 6 weeks
Tegner Lysholm Knee Scoring Scale
The Lysholm Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability).
Measured: 6 months
Tegner Lysholm Knee Scoring Scale
The Lysholm Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability).
Measured: 12 months
Tegner Lysholm Knee Scoring Scale
The Lysholm Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start1 Sep 2021
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre of Postgraduate Medical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafał Kamiński, Centre of Postgraduate Medical Education
- Investigators
- Rafal KAminski, Study chair, CMKP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461651
- Sponsor's protocol ID
- TKA
- Acronym
- TKA_Vanco
- Status last verified
- Jul 2022
- First submitted
- 3 Feb 2022
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes in Prevention of Infection After Total Knee Arthroplasty With or Without Vancomycin.
- ClinicalTrials.gov ID
- NCT05461651
- Acronym / sponsor ID
- TKA_Vanco / TKA
- Conditions
- Infection
- Keywords
- TKA, Vancomycin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Centre of Postgraduate Medical EducationUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 18 Jul 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.
Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes in prevention of infection after Total Knee Arthroplasty With or Without Vancomycin.
Detailed description
Infection after surgery is one of the most common complication after total knee replacement. Our prospective randomized study is intended to show if addition of vancomycin to the joint before the wound closure will decrease infection after operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Knee arthroplasty | Sham comparator | Procedure: Knee arthroplastyKnee arthroplasty without addition of antibiotic wash oraz antibitiotic powder to the surgery site |
| Knee arthroplasty + vancomycin | Active comparator | Procedure: Knee arthroplastyKnee arthroplasty with addition of vancomysin powder to the surgery site |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Gosnartrosis
Key exclusion criteria (1 listed)
- no informed consent to participate in the study age under 40 multilligament injury or single plane knee instability another musculoskeletal disorders in lower limb ASA score > II
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 |
|---|---|---|
| Knee arthroplastytotal or unilateral knee arthroplasty | Procedure or surgery | Knee arthroplasty, Knee arthroplasty + vancomycin |
Primary outcome
Incidence of surgical site infection
Time frame: up to 24 months
The incidence of deep and superficial SSI after knee arthroplasty
22 secondary outcomes
Blood test - CRP
Time frame: 12 weeks,
Blood test - IL 6
Time frame: 12 weeks,
Functional tests
Time frame: 12 weeks,
Functional tests
Time frame: 6 months,
Functional tests
Time frame: 12 months
Functional tests
Time frame: 24 months
Knee injury and Osteoarthritis Outcome Score
Time frame: 6 weeks
Knee injury and Osteoarthritis Outcome Score
Time frame: 6 months
Knee injury and Osteoarthritis Outcome Score
Time frame: 12 months
Knee injury and Osteoarthritis Outcome Score
Time frame: 24 months
36-Item Short Form Survey
Time frame: 6 weeks
36-Item Short Form Survey
Time frame: 6 months
36-Item Short Form Survey
Time frame: 12 months
36-Item Short Form Survey
Time frame: 24 months
Visual analog Scale
Time frame: 6 weeks
Visual analog Scale
Time frame: 6 months
Visual analog Scale
Time frame: 12 months
Visual analog Scale
Time frame: 24 months
Tegner Lysholm Knee Scoring Scale
Time frame: 6 weeks
Tegner Lysholm Knee Scoring Scale
Time frame: 6 months
Tegner Lysholm Knee Scoring Scale
Time frame: 12 months
Tegner Lysholm Knee Scoring Scale
Time frame: 24 months
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 18 Jul 2022.
- 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.
Rafal KAminski study chair
CMKP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knee arthroplasty in people with Infection, run by Centre of Postgraduate Medical Education at 1 site in Poland.
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 1 inclusion and 1 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 18 Jul 2022. 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 Poland. 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?
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 Rafal Kaminski, MD PhD (48 227754031 ext. 469, rkaminski@spskgruca.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of surgical site infection (time frame: up to 24 months). 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 18 Jul 2022.