Comparing One Intraarticular Injection of a Novel HYAJOINT Plus With Synvisc-One for the Treatment of Knee OA

Study Overview
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Brief Summary
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Viscosupplementation has been widely used for the treatment of knee osteoarthritis (OA). There is no well controlled trial comparing one injection regimen of HA for the treatment of knee OA. The purpose of this study was to compare the efficacy and safety of one intraarticular injection of a novel crosslinked HA (HYAJOINT Plus) with Synvisc-One for the treatment of knee OA.

Detailed Description
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In a prospective, randomized controlled, double-blind trial with 6-month follow up, patients with knee OA (Kellgren-Lawrence grade 2 or 3) were randomized to receive one intraarticular injection of 3 ml HYAJOINT Plus (microbial fermented HA, 20 mg/ml) (N=66) or 6 ml Synvisc-One (avian derived HA, 8 mg/ml) (N=66). The primary outcome was change in the visual analog scale (VAS) pain (0-100mm) over 6 months. Secondary outcomes included The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lequesne index, Timed Up-and-Go test (TUG), single leg stance test (SLS), use of rescue analgesics and patient satisfaction.

Official Title
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Comparing Efficacy and Safety of a Single Intraarticular Injection of a Novel Crosslinked Hyaluronic Acid (HYAJOINT Plus) With Synvisc-One for the Treatment of Knee Osteoarthritis: A Randomized-Controlled, Double-Blind Trial

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: HYAJOINT Plus
* Device: Synvisc-One


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: symptomatic knee OA with pain for at least 6 months, despite conservative treatment such as analgesics, NSAIDs and/or physical therapy average pain on knee movement of 30 mm or greater on a 100-mm VAS grade 2 or 3 knee OA according to the Kellgren-Lawrence grading system based on radiographs taken within the previous 6 months Radiological evidence of bilateral knee OA was accepted if global pain VAS in the contralateral knee was less than 30 mm. Exclusion Criteria: previous orthopedic surgery on the spine or lower limbs disabling OA of either hip or foot knee instability, clinical apparent joint effusion or marked valgus/varus deformity known allergy to avian proteins or HA products women ascertained or suspected pregnancy or lactating intraarticular injections within the past 6 months infections or skin diseases around the target knee any specific medical conditions (rheumatoid arthritis, hemiparesis, neoplasm, etc.) that would interfere with the assessments

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 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: the HYAJOINT Plus group<br>the HYAJOINT Plus group received one intraarticular injection of 3 ml HYAJOINT Plus (2% microbial fermented HA, 20 mg/ml). | Device: HYAJOINT Plus<br>* The patients in the HYAJOINT Plus group received one intraarticular injection of 3 ml HYAJOINT Plus (2% microbial fermented HA, 20 mg/ml).<br>* Other names: Hyaluronic acid;|
| Active Comparator: The Synvisc-One group<br>The Synvisc-One group received one injection of 6 ml Synvisc-One (0.8% avian derived HA, 8 mg/ml). | Device: Synvisc-One<br>* The Synvisc-One group received one injection of 6 ml Synvisc-One (0.8% avian derived HA, 8 mg/ml).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS pain score | the change from baseline in the VAS pain score over 6 months. | at 1, 3 and 6 months postinjection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC, Likert Scale | a 24-item questionnaire with 3 subscales measuring pain, stiffness, and physical function. Total score is 96 and lower scores indicate better outcomes. | at 1, 3 and 6 months postinjection | 
| Lequesne index | Maximal score is 24 and higher scores represent worse function. | at 1, 3 and 6 months postinjection | 
| Timed Up-and-Go test (TUG) | a simple measurement of time in seconds for a person to rise from an armchair, walk 3 meters, turn around, walk back to the chair, and sit down | at 1, 3 and 6 months postinjection | 
| Single-leg stance test (SLS) | by raising one foot up without touching it to the supported lower extremity with target knee OA and maintain balance for as long as possible. | at 1, 3 and 6 months postinjection | 
| satisfaction based on a 100 mm VAS | Patients were asked to rate their treatment satisfaction compared to the preinjection condition, based on a 100 mm VAS | at 1, 3 and 6 months postinjection | 
| The reported adverse events | based on adverse events reported by the patients during the study period and physical examination findings by the evaluator after injections and at each follow-up visit | at 1 week (safety records via phone call), 1, 3 and 6 months after the injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee osteoarthritis, Hyaluronic acid, Viscosupplementation