Triamcinolone Ketorolac (TriKe) Knee Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-15

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ketorolac Versus Triamcinolone Knee Injections for Osteoarthritis

NCT02295189

Knee Osteoarthritis

COMPLETED NA

Intraarticular Injections of the Hip and Knee With Triamcinolone Versus Ketorolac: A Randomized Controlled Trial

NCT04441112

Arthritis Knee Arthritis of Hip

COMPLETED PHASE2/PHASE3

Evaluation of the Effect of Adding Corticosteroid to Viscosupplementation

NCT01335321

Osteoarthritis

COMPLETED PHASE4

Knee Injection RCT

NCT03694821

Osteoarthritis

TERMINATED PHASE4

Efficacy of Intra-articular NSAID Versus Corticosteroid in the Treatment of Shoulder and Knee Conditions: A Randomized, Double-Blind, Prospective Study

NCT03616340

Knee Arthritis Shoulder Arthritis Shoulder Impingement +3 more

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis, Knee

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

Triamcinolone acetonide-Ketorolac-Ropivacaine

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

Triamcinolone acetonide-Ketorolac-Ropivacaine

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

Triamcinolone acetonide-Ketorolac-Ropivacaine

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Triamcinolone acetonide-Ketorolac-Ropivacaine

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Exclusion Criteria

* 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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No