RecruitingPhase 4NCT05336968

Triamcinolone Ketorolac (TriKe) Knee Trial

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


Sponsor

United Health Services Hospitals, Inc.

Enrollment

150 participants

Start Date

Sep 15, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 21 Years

Inclusion Criteria5

  • 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 Criteria9

  • 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

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Interventions

DRUGTriamcinolone 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

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NCT05336968


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