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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

Must not have

Systemic steroid use in last 3 months

Uncontrolled diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 -24 weeks

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal 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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken steroids in the last 3 months.

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My diabetes is not under control.

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My BMI is over 50.

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I have kidney disease.

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I cannot walk by myself.

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I am currently using opioids.

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I have had knee surgery in the past year.

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I am allergic or cannot take Cortisone, Ketorolac, or local anesthetics.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 -24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 -24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 -24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

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.

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

0 / 8Eligibility criteria met