Triamcinolone Ketorolac (TriKe) Knee Trial (TriKe)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Drug: Triamcinolone acetonide-Ketorolac-Ropivacaine

Detailed Description

Charts will be prescreened for diagnosis or suspicion of osteoarthritis of the knee by the study staff. Those charts identified will be flagged for possible inclusion in the study. The receptionist will give the prospective subject a copy of the consent to read while they are in the waiting room. Once they are taken back to the room, the investigator will review the study with them. If they are agreeable, they will sign the consent and a copy will be given to them and a copy will be scanned into the Electronic Medical Record (EMR). The investigator will then notify the unblinded investigator, who will randomize the subject and prepare the medication in a blinded fashion. The subject will receive either ketorolac 30 mg, triamcinolone 40 mg, or a combination of the two medications as a one-time injection into the affected knee joint/s. The subject will be asked to complete a survey prior to receiving the injection, and again at 1 week, 6 weeks, and 12 weeks post injection. If necessary, an additional survey will be completed at 24 weeks post injection.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Terri Peters, RN MSN CCRP; Phone Number: 607-763-5697; Email: terri.peters@nyuhs.org
• Study Contact Backup: Name: Benjamin Kammerman, MD; Phone Number: 607-768-7143; Email: benjamin.kammerman@nyuhs.org

Study Locations

• United States
  • New York
    • Vestal, New York, United States, 13850
      • Recruiting
      • United Health Services Sports Medicine Department
      • Contact: Terri K Peters, RN MSN CCRP; Phone Number: 607-763-5697; Email: terri.peters@nyuhs.org
      • Contact: Kathy A Hughes, RN MS; Phone Number: 607-763-5368; Email: kathy.hughes@nyuhs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Triamcinolone acetonide-Ketorolac-Ropivacaine; Experimental for Osteoarthrosis of the Knee. One randomized injection to intraarticularly into affected knee at time of 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	Drug: Triamcinolone acetonide-Ketorolac-Ropivacaine; Experimental for Osteoarthrosis of the Knee. One randomized injection to intraarticularly into affected knee at time of 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	Drug: Triamcinolone acetonide-Ketorolac-Ropivacaine; Experimental for Osteoarthrosis of the Knee. One randomized injection to intraarticularly into affected knee at time of randomization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in patient reported outcomes as measured by Modified KOOS scores	Change in patient reported outcomes as measured by Modified Knee Injury and Osteoarthritis Outcome Score (KOOS, higher is better [0-100]).	12 -24 weeks
Evaluate whether the combination of ketorolac and cortisone is superior to either alone as measured by Modified KOOS	Change in patient reported outcomes as measured by Modified Knee Injury and Osteoarthritis Outcome Score (KOOS, higher is better [0-100])	12 -24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in patient reported outcomes as measured by VAS	Change in patient reported outcomes as measured by Visual Analog Scale (VAS, lower is better [0-100])	12 -24 weeks
Evaluate whether the combination of ketorolac and cortisone is superior to either alone as measured by VAS	Change in patient report outcomes as measured by Visual Analog Scale (VAS, lower is better [0-100])	12 -24 weeks

Collaborators and Investigators

• Sponsor: United Health Services Hospitals, Inc.
• Investigators: Principal Investigator: Stanley Hunter, MD, United Health Services Hospitals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anesthetics, Local; Ketorolac; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate; Ropivacaine
• Other Study ID Numbers: UHSH-9940

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes