RECRUITING

Triamcinolone Ketorolac (TriKe) Knee Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-09-15
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05336968

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Knee pain with diagnosis of osteoarthritis/osteoarthrosis
  2. * Weight-bearing x-rays within the last year adequate to assess Kellgran-Lawrence OA stage
  3. * Age \> 21
  4. * English proficiency sufficient to complete surveys
  5. * Willing to complete follow-up surveys
  1. * Prior knee injection in last 3 months
  2. * Knee surgery within the last year
  3. * Contraindications to Cortisone, Ketorolac, or local anesthetic
  4. * Uncontrolled diabetes
  5. * Systemic steroid use in last 3 months
  6. * BMI \> 50
  7. * Non-ambulatory
  8. * Known kidney disease
  9. * Current opioid use

Contacts and Locations

Study Contact

Terri Peters, RN MSN CCRP
CONTACT
607-763-5697
terri.peters@nyuhs.org
Benjamin Kammerman, MD
CONTACT
607-768-7143
benjamin.kammerman@nyuhs.org

Principal Investigator

Stanley Hunter, MD
PRINCIPAL_INVESTIGATOR
United Health Services Hospitals, Inc.

Study Locations (Sites)

United Health Services Sports Medicine Department
Vestal, New York, 13850
United States

Collaborators and Investigators

Sponsor: United Health Services Hospitals, Inc.

  • Stanley Hunter, MD, PRINCIPAL_INVESTIGATOR, United Health Services Hospitals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-15
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2022-09-15
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Osteoarthritis, Knee