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Comparing vancomycin drug given through bone and vancomycin drug given through blood in knee replacement patients

Comparison of intraosseous and intravenous Vancomycin in Total Knee Arthroplasty - A Randomised Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070301
Enrollment
100
Registered
2024-07-09
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M170- Bilateral primary osteoarthritis of knee Health Condition 2: M171- Unilateral primary osteoarthritisof knee

Interventions

Intervention1: Vancomycin: Intraosseos Intraosseous (IO) vancomycin (500 mg in 100cc of normal saline) injected into the medial condyle of femur and tibia in 2 divided dose one time after incision b

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Any subject more than 18 years of age who is undergoing a primary TKR for osteoarthritis and given consent for the procedure.

Exclusion criteria

Exclusion criteria: Past knee surgery (including knee scopes), allergy, patients with bleeding disorder and immunocompromised and/or immunosuppressed patients (HIV, Hepatitis B/C, end stage renal disease (ESRD), post-transplant, chemotherapy or radiation therapy, medications which are immunomodulating).

Design outcomes

Primary

MeasureTime frame
demonstrate the utility of intra osseous vancomycin over Intravenous Vancomycin in primary TKR with improved local tissue concentration and decreased systemic concentrations.Timepoint: 4 weeks

Secondary

MeasureTime frame
NoneTimepoint: None

Countries

India

Contacts

Public ContactAakarsh Aggarwal

All India institute of medical sciences Jodhpur

aakarshaggarwal1@gmail.com9015759696

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026