Knee Injection RCT

Study Overview
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Brief Summary
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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
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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).

Official Title
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Efficacy and Cost-effectiveness of Intra-Articular Ketorolac Injection for Knee Osteoarthritis: A Randomized, Controlled, Double-Blinded Study

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: Ketorolac Tromethamine Injection
* Drug: Methylprednisolone Acetate Injection
* Drug: Hylan G-F 20


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketorolac<br>One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine | Drug: Ketorolac Tromethamine Injection<br>* One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine<br>* Other names: Ketorolac Tromethamine; NDC 63323-162-02; J Code J1885;|
| Active Comparator: Corticosteroid<br>One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine | Drug: Methylprednisolone Acetate Injection<br>* One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine<br>* Other names: DEPO-MEDROL; NDC 0009-3073-01; J Code J1030;|
| Active Comparator: Hyaluronic Acid<br>One knee injection of Hylan G-F 20 (Synvisc-One) | Drug: Hylan G-F 20<br>* One knee injection of Hylan G-F 20 (Synvisc-One)<br>* Other names: Synvisc-One; NDC 58468-0090-03; J Code J7325;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Pain Scale (VAS) | average knee pain between 0 (no pain) and 10 (worst pain) 3 months following injection | 3 months post injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | self-reported pain, stiffness and functioning | 3 and 6 months post injection | 
| Oxford Knee Questionnaire | self-reported pain, stiffness and functioning | 3 and 6 months post injection | 
| Koos, Jr. Knee Survey | self-reported pain, stiffness and functioning | 3 and 6 months post injection | 
| Visual Analogue Pain Scale (VAS) | average knee pain between 0 (no pain) and 10 (worst pain) 6 months following injection | 6 months | 
| Patient Satisfaction | satisfaction with treatment rated as Yes or No | 3 and 6 months post injection | 
| Non-routine Visits Due to Inadequate Pain Relief or Complications | Any additional visits due to inadequate pain relief or complications | 3 months post injection | 
| Cost of Intervention | cost of each injection | 3 months post injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Knee, Injection, Ketorolac