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Triamcinolone Ketorolac (TriKe) Knee Trial (TriKe)

Primary Purpose

Osteoarthritis, Knee

Status
Enrolling by invitation
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Triamcinolone acetonide-Ketorolac-Ropivacaine
Sponsored by
United Health Services Hospitals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

Sites / Locations

  • United Health Services Sports Medicine Department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Triamcinolone acetonide - Ropivacaine - Normal Saline

Ketorolac - Ropivacaine - Normal Saline

Triamcinolone acetonide - Ketorolac - Ropivacaine

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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]).
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])

Secondary Outcome Measures

Change in patient reported outcomes as measured by VAS
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
Change in patient report outcomes as measured by Visual Analog Scale (VAS, lower is better [0-100])

Full Information

First Posted
February 7, 2022
Last Updated
May 10, 2023
Sponsor
United Health Services Hospitals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05336968
Brief Title
Triamcinolone Ketorolac (TriKe) Knee Trial
Acronym
TriKe
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
United Health Services Hospitals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Triamcinolone acetonide - Ropivacaine - Normal Saline
Arm Type
Active Comparator
Arm Description
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
Arm Title
Ketorolac - Ropivacaine - Normal Saline
Arm Type
Experimental
Arm Description
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
Arm Title
Triamcinolone acetonide - Ketorolac - Ropivacaine
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Triamcinolone acetonide-Ketorolac-Ropivacaine
Intervention Description
Experimental for Osteoarthrosis of the Knee. One randomized injection to intraarticularly into affected knee at time of randomization
Primary Outcome Measure Information:
Title
Change in patient reported outcomes as measured by Modified KOOS scores
Description
Change in patient reported outcomes as measured by Modified Knee Injury and Osteoarthritis Outcome Score (KOOS, higher is better [0-100]).
Time Frame
12 -24 weeks
Title
Evaluate whether the combination of ketorolac and cortisone is superior to either alone as measured by Modified KOOS
Description
Change in patient reported outcomes as measured by Modified Knee Injury and Osteoarthritis Outcome Score (KOOS, higher is better [0-100])
Time Frame
12 -24 weeks
Secondary Outcome Measure Information:
Title
Change in patient reported outcomes as measured by VAS
Description
Change in patient reported outcomes as measured by Visual Analog Scale (VAS, lower is better [0-100])
Time Frame
12 -24 weeks
Title
Evaluate whether the combination of ketorolac and cortisone is superior to either alone as measured by VAS
Description
Change in patient report outcomes as measured by Visual Analog Scale (VAS, lower is better [0-100])
Time Frame
12 -24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanley Hunter, MD
Organizational Affiliation
United Health Services Hospitals, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
United Health Services Sports Medicine Department
City
Vestal
State/Province
New York
ZIP/Postal Code
13850
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Triamcinolone Ketorolac (TriKe) Knee Trial

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