Recruiting

Triamcinolone & Ketorolac

Sponsor:

United Health Services Hospitals, Inc.

Code:

NCT05336968

Conditions

Osteoarthritis, Knee

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Triamcinolone acetonide-Ketorolac-Ropivacaine

Study Details

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

Study ID

NCT05336968

Start date

Sep 15, 2022

Status verified date

May, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Nov 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not 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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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

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

Interventions

Triamcinolone acetonide-Ketorolac-Ropivacaine

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

Primary outcome measure

  • Change in patient reported outcomes as measured by Modified KOOS scores [ Time Frame: 12 -24 weeks ]
  • Evaluate whether the combination of ketorolac and cortisone is superior to either alone as measured by Modified KOOS [ Time Frame: 12 -24 weeks ]

Central Contacts and Locations

Central contacts

Locations

United Health Services Sports Medicine Department

Recruiting

Vestal, New York, United States, 13850

Contacts

Terri K Peters, RN MSN CCRP

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

More Information

Sponsor

United Health Services Hospitals, Inc.

Last update posted

May 8, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by United Health Services Hospitals, Inc. on 2024-05-08.