Clinical trial NCT05336968: Triamcinolone Ketorolac (TriKe) Knee Trial
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
Overall status: RECRUITING
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Lead sponsor: United Health Services Hospitals, Inc.
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in patient reported outcomes as measured by Modified KOOS scores
timeFrame: 12 -24 weeks
measure: Evaluate whether the combination of ketorolac and cortisone is superior to either alone as measured by Modified KOOS
timeFrame: 12 -24 weeks
Secondary outcomes:
measure: Change in patient reported outcomes as measured by VAS
timeFrame: 12 -24 weeks
measure: Evaluate whether the combination of ketorolac and cortisone is superior to either alone as measured by VAS
timeFrame: 12 -24 weeks
Other outcomes:
Locations:
city: Vestal
country: United States
facility: United Health Services Sports Medicine Department
state: New York
Study officials:
affiliation: United Health Services Hospitals, Inc.
name: Stanley Hunter, MD
role: PRINCIPAL_INVESTIGATOR
References: