Clinical trial NCT03694821: Knee Injection RCT
Official title: Efficacy and Cost-effectiveness of Intra-Articular Ketorolac Injection for Knee Osteoarthritis: A Randomized, Controlled, Double-Blinded Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: Osteoarthritis
Knee
Injection
Ketorolac
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: Orthopedic Research and Education Foundation
First posted: 2018-10-03
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis: Ketorolac injection is a cost-effective adjunct in the nonoperative treatment of knee osteoarthritis (OA) compared to steroids and viscosupplementation.

Aims/objectives: The objective of this randomized, controlled, double-blinded, prospective study is to assess the efficacy and cost-effectiveness of knee injection with ketorolac in the nonsurgical management of symptomatic OA compared to injections with corticosteroids and viscosupplements.

Detailed description: The purpose of this research study is to examine the effectiveness of intra-articular (inside the joint) ketorolac injection compared to injection with either corticosteroid or hyaluronic acid for the treatment of painful knee osteoarthritis. Patients will be randomly assigned to receive either ketorolac (a nonsteroidal anti-inflammatory drug, methylprednisolone (a steroid), hyaluronic acid (a substance that is naturally present in the human body).

Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18 who present with 1) symptomatic knee OA and radiographic evidence of joint space narrowing and 2) are interested in knee injections for pain relief.

Exclusion Criteria:

* Prior injections into the same knee within the past 6 months,
* Pregnant and/or lactating women,
* Inflammatory joint disease including rheumatoid or psoriatic arthritis,
* Concurrent use of anti-rheumatic drugs,
* Allergy or hypersensitivity to the study medications,
* Patients on an active pain management contract,
* Patients with insurance that requires pre-certification for any of the study drugs,
* Inability to make own decisions regarding the informed consent,
* Inability to read and/or understand English,
* Patients who are unable to return for follow-up or be reached by phone.

Primary outcomes:
measure: Visual Analogue Pain Scale (VAS)
timeFrame: 3 months post injection
Secondary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 3 and 6 months post injection
measure: Oxford Knee Questionnaire
timeFrame: 3 and 6 months post injection
measure: Koos, Jr. Knee Survey
timeFrame: 3 and 6 months post injection
measure: Visual Analogue Pain Scale (VAS)
timeFrame: 6 months
measure: Patient Satisfaction
timeFrame: 3 and 6 months post injection
measure: Non-routine Visits Due to Inadequate Pain Relief or Complications
timeFrame: 3 months post injection
measure: Cost of Intervention
timeFrame: 3 months post injection
Other outcomes:
Locations:
city: Farmington
country: United States
facility: UConn Health
state: Connecticut
Study officials:
affiliation: UConn Health
name: Mohamad J. Halawi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Bellamy JL, Goff BJ, Sayeed SA. Economic Impact of Ketorolac vs Corticosteroid Intra-Articular Knee Injections for Osteoarthritis: A Randomized, Double-Blind, Prospective Study. J Arthroplasty. 2016 Sep;31(9 Suppl):293-7. doi: 10.1016/j.arth.2016.05.015. Epub 2016 May 18.