Triamcinolone Ketorolac (TriKe) Knee Trial

• Status: Not yet recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: United Health Services Hospitals, Inc.
• Treatments: Ketorolac; Ropivacaine; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

• Knee pain with diagnosis of osteoarthritis/osteoarthrosis

• Weight-bearing x-rays within the last year adequate to assess Kellgran-Lawrence OA stage

• Age > 21

• English proficiency sufficient to complete surveys

• Willing to complete follow-up surveys

Exclusion Criteria:

• Prior knee injection in last 3 months

• Knee surgery within the last year

• Contraindications to Cortisone, Ketorolac, or local anesthetic

• Uncontrolled diabetes

• Systemic steroid use in last 3 months

• BMI > 50

• Non-ambulatory

• Known kidney disease

• Current opioid use