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RECRUITING
NCT05336968
PHASE4

Triamcinolone Ketorolac (TriKe) Knee Trial

Sponsor: United Health Services Hospitals, Inc.

View on ClinicalTrials.gov

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.

Official title: Triamcinolone Ketorolac (TriKe) Knee Trial Evaluating the Effectiveness and Possible Superiority of Ketorolac vs. Cortisone When Injected Intra-Articular in Subjects With Osteoarthrosis

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2022-09-15

Completion Date

2025-12-31

Last Updated

2024-05-08

Healthy Volunteers

No

Interventions

DRUG

Triamcinolone acetonide-Ketorolac-Ropivacaine

Experimental for Osteoarthrosis of the Knee. One randomized injection to intraarticularly into affected knee at time of randomization

Locations (1)

United Health Services Sports Medicine Department

Vestal, New York, United States