Triamcinolone Ketorolac (TriKe) Knee Trial

Description

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.

Conditions

Osteoarthritis, Knee

Study Overview

Study Details

Study overview

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.

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

Triamcinolone Ketorolac (TriKe) Knee Trial

Condition
Osteoarthritis, Knee
Intervention / Treatment

-

Contacts and Locations

Vestal

United Health Services Sports Medicine Department, Vestal, New York, United States, 13850

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

United Health Services Hospitals, Inc.,

Stanley Hunter, MD, PRINCIPAL_INVESTIGATOR, United Health Services Hospitals, Inc.

Study Record Dates

2025-12-31