A Study Comparing Viscosupplementation and Corticosteroid Injections for Knee Osteoarthritis
NCT ID: NCT01132677
Last Updated: 2010-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
78 participants
INTERVENTIONAL
2010-05-31
2011-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Hyaluronic Acid (HA) Injection
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.
Hylan G-F 20 (Synvisc One)
Single IA injection of 6cc's. Injections will be administered as outlined on the company label.
Corticosteroid Injection
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.
Methylprednisolone (Corticosteroid)
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.
Interventions
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Hylan G-F 20 (Synvisc One)
Single IA injection of 6cc's. Injections will be administered as outlined on the company label.
Methylprednisolone (Corticosteroid)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
75 Years
ALL
No
Sponsors
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LifeMark Health
OTHER
Responsible Party
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LifeMark Health
Principal Investigators
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Brad J Monteleone, Physician
Role: PRINCIPAL_INVESTIGATOR
UBC - Department of Family Practice
Locations
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LifeMark Health
Kelowna, British Columbia, Canada
Countries
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Other Identifiers
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HA-CS-OA1
Identifier Type: -
Identifier Source: org_study_id