Triamcinolone Ketorolac (TriKe) Knee Trial

NCT05336968 | Recruiting Phase 4 FDA Drug

• 1 other identifier: UHSH-9940
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in patient reported outcomes as measured by VAS

  12 -24 weeks

• Evaluate whether the combination of ketorolac and cortisone is superior to either alone as measured by VAS

  12 -24 weeks

Study Arms (3)

Triamcinolone acetonide - Ropivacaine - Normal Saline

ACTIVE COMPARATOR

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

Ketorolac - Ropivacaine - Normal Saline

EXPERIMENTAL

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

Triamcinolone acetonide - Ketorolac - Ropivacaine

EXPERIMENTAL

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

Interventions

Triamcinolone acetonide-Ketorolac-Ropivacaine DRUG

Experimental for Osteoarthrosis of the Knee. One randomized injection to intraarticularly into affected knee at time of randomization

Ketorolac - Ropivacaine - Normal Saline; Triamcinolone acetonide - Ketorolac - Ropivacaine; Triamcinolone acetonide - Ropivacaine - Normal Saline

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• United Health Services Hospitals, Inc.: lead

Study Sites (1)

United Health Services Sports Medicine Department

Vestal, New York, 13850, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Stanley Hunter, MD

  United Health Services Hospitals, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Terri Peters, RN MSN CCRP

CONTACT

607-763-5697; terri.peters@nyuhs.org

Benjamin Kammerman, MD

CONTACT

607-768-7143; benjamin.kammerman@nyuhs.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All staff working with the study subjects will be blinded. Once the subject signs consent, an unblinded study doctor will, using a special method, draw up the appropriate medication and blind the syringe so the the staff giving the medication will not know what is being given.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, UHSH Concussion Center

Model Details: Subjects will receive either ketorolac 30 mg, triamcinolone 40 mg, or a combination of the two medications as a one-time injection into one or both affected knee joint/s.

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: April 20, 2022
• Study Start: September 15, 2022
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

US (1)