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Non-Steroidal Anti-Inflammatory Drug
Triamcinolone + Ketorolac for Knee Osteoarthritis (TriKe Trial)
Phase 4
Recruiting
Led By Stanley Hunter, MD
Research Sponsored by United Health Services Hospitals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 -24 weeks
Awards & highlights
TriKe Trial Summary
This trial compares the effects of cortisone and ketorolac injections to treat knee osteoarthritis. Combining them may improve outcomes and reduce adverse effects.
Who is the study for?
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.Check my eligibility
What is being tested?
The trial is testing injections into the knee joint: one with a cortisone drug called Triamcinolone, another with an anti-inflammatory called Ketorolac, and a mix of both. It aims to see if Ketorolac alone or combined with Triamcinolone works better than just Triamcinolone for knee arthritis.See study design
What are the potential side effects?
Possible side effects include tissue atrophy near the injection site and faster joint degeneration from cortisone; gastrointestinal issues, kidney problems, or increased bleeding risk from Ketorolac; and numbness or weakness due to Ropivacaine.
TriKe Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 -24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 -24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in patient reported outcomes as measured by Modified KOOS scores
Evaluate whether the combination of ketorolac and cortisone is superior to either alone as measured by Modified KOOS
Secondary outcome measures
Change in patient reported outcomes as measured by VAS
Evaluate whether the combination of ketorolac and cortisone is superior to either alone as measured by VAS
TriKe Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Triamcinolone acetonide - Ketorolac - RopivacaineExperimental Treatment1 Intervention
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
Group II: Ketorolac - Ropivacaine - Normal SalineExperimental Treatment1 Intervention
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
Group III: Triamcinolone acetonide - Ropivacaine - Normal SalineActive Control1 Intervention
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
Find a Location
Who is running the clinical trial?
United Health Services Hospitals, Inc.Lead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
Stanley Hunter, MDPrincipal InvestigatorUnited Health Services Hospitals, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken steroids in the last 3 months.My diabetes is not under control.You can speak and understand English well enough to answer survey questions.I have not had a knee injection in the last 3 months.My BMI is over 50.I have kidney disease.I cannot walk by myself.I am currently using opioids.I have had knee surgery in the past year.I am allergic or cannot take Cortisone, Ketorolac, or local anesthetics.I am older than 21 years.I am willing to fill out follow-up surveys.I have knee pain due to osteoarthritis.I have had x-rays within the last year to check the stage of my arthritis.
Research Study Groups:
This trial has the following groups:- Group 1: Triamcinolone acetonide - Ketorolac - Ropivacaine
- Group 2: Ketorolac - Ropivacaine - Normal Saline
- Group 3: Triamcinolone acetonide - Ropivacaine - Normal Saline
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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