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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
United Health Services Sports Medicine Department
RECRUITING
Vestal
Contact Information
Primary
Terri Peters, RN MSN CCRP
terri.peters@nyuhs.org
607-763-5697
Backup
Benjamin Kammerman, MD
benjamin.kammerman@nyuhs.org
607-768-7143
Time Frame
Start Date: 2022-09-15
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 150
Treatments
Active_comparator: Triamcinolone acetonide - Ropivacaine - Normal Saline
Subject would receive:~Triamcinolone acetonide, 40 mg/mL. 1 mL Ropivacaine 0.2%, 2 mL Saline 0.9% 1 mL for a total of 4 mL injected intraarticularly into affected knee/s at randomization
Experimental: Ketorolac - Ropivacaine - Normal Saline
Subject would receive:~Ketorolac 30 mg/mL, 1 mL Ropivacaine 0.2%, 2 mL Saline 0.9% 1 mL for a total of 4 mL injected intraarticularly into affected knee/s at randomization
Experimental: Triamcinolone acetonide - Ketorolac - Ropivacaine
Subject would receive:~Triamcinolone acetonide, 40 mg/mL Ketorolac 30 mg/mL, 1 mL Ropivacaine 0.2%, 2 mL for a total of 4 mL injected intraarticularly into affected knee/s at randomization
Related Therapeutic Areas
Sponsors
Leads: United Health Services Hospitals, Inc.

This content was sourced from clinicaltrials.gov