A Study Comparing Viscosupplementation and Corticosteroid Injections for Knee Osteoarthritis

Study Overview
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Brief Summary
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Do differences exist between patients who receive a single intra-articular injection of corticosteroid versus patients who receive a single intra-articular injection of hyaluronic acid for the treatment of knee osteoarthritis at 1, 3 and 6 weeks, and 3 and 6 months post injection?

Detailed Description
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OBJECTIVES Primary i. To determine if patients' VAS pain while walking is different at 6 weeks post-injection in patients who receive a single injection of methylprednisolone acetate (MPA) versus patients who receive a single injection of Hylan G-F 20 (Synvisc One™) for treatment of knee OA. Secondary i. To determine if differences in VAS pain while walking scores exist at 1 and 3 weeks, and 3 and 6 months post injection between MPA and HA patients. ii. To determine if differences in VAS pain at rest scores exist at 1, 3 and 6 weeks and 3 and 6 months post injection between MPA and HA patients. iii. To determine if differences in VAS pain with stairs scores exist at 1, 3 and 6 weeks and 3 and 6 months post injection between MPA and HA patients. iii. To determine if differences in KOOS questionnaire scores exist at 6 weeks, 3 months and 6 months post injection between MPA and HA patients. iv. To determine if differences in WOMAC questionnaire scores exist at 6 weeks, 3 months, and 6 months post injection between MPA and HA patients. v. To determine if differences in adverse events exist at 1, 3 and 6 weeks, and 3, and 6 months post injection between MPA and HA patients. vi. To track the number of patients who receive additional injections after 3 months following their index injection.

Official Title
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A Randomized Clinical Trial Comparing Hyaluronic Acid (Hylan G-F 20) and Corticosteroid (Methylprednisolone Acetate) for Knee Osteoarthritis

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: Hylan G-F 20 (Synvisc One)
* Drug: Methylprednisolone (Corticosteroid)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical 19-75 years of age (inclusive) Symptomatic OA (1 of the following: pain, stiffness, or swelling) Evidence of grade I, II or III OA on radiographic images according to Kellgren-Lawrence grading scale. Exclusion Criteria: Clinical Previous surgery on either knee (not including a diagnostic arthroscopy arthroscopy or simple partial meniscectomy) Intra-articular treatment within the last 3 months Ipsilateral cruciate or collateral ligament injury within past 3 months, or evidence of ligament laxity Inflamed knee or pronounced effusion Allergy to birds, eggs, avian proteins or known HA or corticosteroid Venous or lymphatic stasis Skin condition in the injection area Evidence of infection in the affected joint History of crystalline arthropathy or inflammatory arthritis Pregnant or nursing Third Party, Medical Legal or Workers' Compensation Board Patient unable to understand English or unable to providing informed consent

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 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 |
| --- | --- |
| Active Comparator: Hyaluronic Acid (HA) Injection<br>Patients allocated to the HA group will receive a single IA injection Hylan G-F 20 Synvisc One™ (1 injection of 6cc's). All injections will be administered as outlined on the company label. Aspiration of the knee will not be performed. | Device: Hylan G-F 20 (Synvisc One)<br>* Single IA injection of 6cc's. Injections will be administered as outlined on the company label.<br>|
| Active Comparator: Corticosteroid Injection<br>Patients allocated to the corticosteroid injection will receive a single IA injection of 80mg of methylprednisolone acetate (1cc of solution) mixed with 5cc's of 1% lidocaine without epinephrine for a total of 6cc's. The injection will be administered as outlined on the company label. Aspiration of the knee will not be performed. | Drug: Methylprednisolone (Corticosteroid)<br>* Single IA injection of 80mg of methylprednisolone acetate (1cc of solution) mixed with 5cc's of 1% lidocaine without epinephrine for a total of 6cc's. The injection will be administered as outlined on the company label.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome will be pain while walking for approximately 30 minutes on a flat surface today as reported by the patient on a 100mm unmarked VAS (0 = no pain; 100 = worst pain possible). | As described in title | VAS Form will be given at baseline (prior to injection) and then at 1, 3 and 6 weeks, and 3 and 6 months post injection. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at rest or with stairs as reported byu the patient on a VAS | Secondary Outcomes: i. Pain at rest and pain with stairs as reported by the patient on a VAS (Additional outcomes ii. Knee injury and Osteoarthritis Outcome Score (KOOS). The KOOS is a valid, reliable and responsive questionnaire that is self-administered and consists of 5 subscales. iii. The KOOS includes the WOMAC Osteoarthritis Index LK 3.0 and thus, WOMAC scores will also be computed. iv. Adverse events as reviewed and documented by the physician v. The number of subsequent re-injections or treatment strategies.) | Baseline (pre-injection), 1, 3 and 6 weeks, and 3 and 6 months post injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OA of Knee, Osteoarthritis of Knee, Viscosupplementation and Osteoarthritis, Viscosupplementation and OA, Hyaluronic Acid, Corticosteroid injection versus hyaluronic acid, Synvisc One and Knee OA, viscosupplementation and knee pain, knee Pain from OA