drugset / Trial / NCT05336968

Triamcinolone Ketorolac (TriKe) Knee Trial

NCT05336968

Phase 4 Unknown 150 enrolled United Health Services Hospitals, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Cortisone injections are commonly used in the treatment of osteoarthrosis of the knee, but there are known detriments to cortisone including localized tissue atrophy near the injection site and acceleration of joint degeneration, as well as contraindications, such as uncontrolled diabetes. Ketorolac is a non-steroidal anti-inflammatory with decades of clinical data that is most commonly injected intramuscularly. There is rising interest in using ketorolac as an intra-articular injectant substitute or adjunctive to cortisone. This may potentially improve clinical outcomes or decrease adverse effects. Although intra-articular use of ketorolac is increasing in orthopedics and sports medicine, there is limited data in the literature comparing these two injectants in prospective, randomized trials, and no data that evaluates combining the two injectants. Primary objectives are to evaluate the efficacy of intra-articular ketorolac compared to cortisone on knee osteoarthrosis and to evaluate whether the combination of ketorolac and cortisone is superior to either alone.

Timeline

Start
2022-09-15
Primary completion
2025-11-30
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketorolac Other / unclassified 30 mg Other
Subject Triamcinolone Acetonide Other / unclassified 40 mg Other
Background Ropivacaine Other / unclassified 0.2 % Other

Indications