Triamcinolone Ketorolac (TriKe) Knee Trial

Osteoarthritis, Knee Clinical Trial

— TriKe  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05336968
• Other study ID #: UHSH-9940
• Status: Recruiting
• Phase: Phase 4
• Start date: September 15, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: United Health Services Hospitals, Inc.
• Contact: Terri Peters, RN MSN CCRP
• Phone: 607-763-5697
• Email: terri.peters[@]nyuhs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Drug:
• Triamcinolone acetonide-Ketorolac-Ropivacaine
Experimental for Osteoarthrosis of the Knee. One randomized injection to intraarticularly into affected knee at time of randomization

Locations

Country	Name	City	State
United States	United Health Services Sports Medicine Department	Vestal	New York

Sponsors (1)

Lead Sponsor	Collaborator
United Health Services Hospitals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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