Title
A Study Comparing Viscosupplementation and Corticosteroid Injections for Knee Osteoarthritis
A Randomized Clinical Trial Comparing Hyaluronic Acid (Hylan G-F 20) and Corticosteroid (Methylprednisolone Acetate) for Knee Osteoarthritis
Phase
N/ALead Sponsor
LifeMark HealthStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Osteoarthritis, KneeIntervention/Treatment
methylprednisolone hyaluronic acid ...Study Participants
78Do 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?
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.
Single IA injection of 6cc's. Injections will be administered as outlined on the company label.
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.
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.
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.
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
