Triamcinolone + Ketorolac for Knee Osteoarthritis
(TriKe Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used systemic steroids or opioids in the last 3 months.
Is the combination of Triamcinolone and Ketorolac generally safe for humans?
How is the drug combination of Triamcinolone and Ketorolac unique for knee osteoarthritis?
This treatment combines Triamcinolone, a corticosteroid that reduces inflammation, with Ketorolac, a non-steroidal anti-inflammatory drug (NSAID) that relieves pain, offering a dual approach to managing knee osteoarthritis. The extended-release formulation of Triamcinolone allows for prolonged relief with reduced systemic side effects, making it a novel option compared to standard corticosteroid treatments.678910
Who Is on the Research Team?
Stanley Hunter, MD
Principal Investigator
United Health Services Hospitals, Inc.
Are You a Good Fit for This Trial?
This trial is for adults over 21 with knee pain from osteoarthritis, who can speak English well enough to fill out surveys. They must have had weight-bearing x-rays within the last year to check their arthritis stage and be willing to complete follow-up surveys.Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a one-time intra-articular injection of either ketorolac, triamcinolone, or a combination of both into the affected knee joint/s
Follow-up
Participants are monitored for safety and effectiveness after treatment, with surveys completed at 1 week, 6 weeks, 12 weeks, and possibly 24 weeks post-injection
What Are the Treatments Tested in This Trial?
Interventions
- Ketorolac
- Ropivacaine
- Triamcinolone acetonide
Ketorolac is already approved in United States, European Union, Switzerland for the following indications:
- Moderate to severe pain
- Postoperative pain
- Dysmenorrhea
- Idiopathic pericarditis
- Ocular itching
- Moderate to severe pain
- Postoperative pain
- Dysmenorrhea
- Ocular itching
- Inflammation after eye surgery
- Moderate to severe pain
- Moderate to severe pain
- Postoperative pain
Find a Clinic Near You
Who Is Running the Clinical Trial?
United Health Services Hospitals, Inc.
Lead Sponsor