NCT05461651

Brief Summary

Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes in prevention of infection after Total Knee Arthroplasty With or Without Vancomycin.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,800

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Sep 2021Jan 2029

Study Start

First participant enrolled

September 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 18, 2022

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

July 18, 2022

Status Verified

July 1, 2022

Enrollment Period

6.3 years

First QC Date

February 3, 2022

Last Update Submit

July 13, 2022

Conditions

Infection

Keywords

TKA, Vancomycin

Outcome Measures

Primary Outcomes (1)

  • Incidence of surgical site infection

    The incidence of deep and superficial SSI after knee arthroplasty

    up to 24 months

Secondary Outcomes (22)

  • Blood test - CRP

    12 weeks,

  • Blood test - IL 6

    12 weeks,

  • Functional tests

    12 weeks,

  • Functional tests

    6 months,

  • Functional tests

    12 months

  • +17 more secondary outcomes

Study Arms (2)

Knee arthroplasty

SHAM COMPARATOR

Knee arthroplasty without addition of antibiotic wash oraz antibitiotic powder to the surgery site

Procedure: Knee arthroplasty

Knee arthroplasty + vancomycin

ACTIVE COMPARATOR

Knee arthroplasty with addition of vancomysin powder to the surgery site

Procedure: Knee arthroplasty

Interventions

Knee arthroplastyPROCEDURE

total or unilateral knee arthroplasty

Knee arthroplastyKnee arthroplasty + vancomycin

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gosnartrosis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopaedics and Traumatology, Postgraduate Center for Medical Education, Professor A. Gruca Teaching Hospital

Otwock, Masovian Voivodeship, 05-400, Poland

RECRUITING

MeSH Terms

Conditions

Infections

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Rafal KAminski

    CMKP

    STUDY CHAIR

Central Study Contacts

Rafal Kaminski, MD PhD

CONTACT

48 227754031rkaminski@spskgruca.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 3, 2022

First Posted

July 18, 2022

Study Start

September 1, 2021

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

July 18, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)