Triamcinolone Ketorolac (TriKe) Knee Trial

Sponsor

United Health Services Hospitals, Inc. (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05336968

Collaborator

(none)

150

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee	Drug: Triamcinolone acetonide-Ketorolac-Ropivacaine	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

May 31, 2022

Anticipated Primary Completion Date :

May 31, 2023

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Triamcinolone acetonide - Ropivacaine - Normal Saline 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 Experimental for Osteoarthrosis of the Knee. One randomized injection to intraarticularly into affected knee at time of randomization
Experimental: Ketorolac - Ropivacaine - Normal Saline 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 Experimental for Osteoarthrosis of the Knee. One randomized injection to intraarticularly into affected knee at time of randomization
Experimental: Triamcinolone acetonide - Ketorolac - Ropivacaine 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 Experimental for Osteoarthrosis of the Knee. One randomized injection to intraarticularly into affected knee at time of randomization

Arm

Intervention/Treatment

Active Comparator: Triamcinolone acetonide - Ropivacaine - Normal Saline

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

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

Experimental: Ketorolac - Ropivacaine - Normal Saline

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

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

Experimental: Triamcinolone acetonide - Ketorolac - Ropivacaine

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

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

Outcome Measures

Primary Outcome Measures

Change in patient reported outcomes as measured by Modified KOOS scores [12 -24 weeks]
Change in patient reported outcomes as measured by Modified Knee Injury and Osteoarthritis Outcome Score (KOOS, higher is better [0-100]).
Evaluate whether the combination of ketorolac and cortisone is superior to either alone as measured by Modified KOOS [12 -24 weeks]
Change in patient reported outcomes as measured by Modified Knee Injury and Osteoarthritis Outcome Score (KOOS, higher is better [0-100])

Secondary Outcome Measures

Change in patient reported outcomes as measured by VAS [12 -24 weeks]
Change in patient reported outcomes as measured by Visual Analog Scale (VAS, lower is better [0-100])
Evaluate whether the combination of ketorolac and cortisone is superior to either alone as measured by VAS [12 -24 weeks]
Change in patient report outcomes as measured by Visual Analog Scale (VAS, lower is better [0-100])

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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