The Comparison of HYAJOINT Plus and Hyalgan Hyaluronan Supplement for Knee Osteoarthritis Pain

Study Overview
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Brief Summary
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The aim of this study was to compare single injection HYAJOINT Plus Synovial Fluid Supplement used on the single and repeat treatment of knee osteoarthritis that has the same safety and effectiveness as three-injection hyaluronan, Hyalgan.

Detailed Description
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The study was a random, evaluator-blinded, controlled, single center clinical trial. Recruiting patients who have been suffered from the osteoarthritis pain under conventional nonpharmacologic therapy or analgesics for a long time and randomly divided into two groups, HYAJOINT Plus or Hyalgan group, when the inclusion criteria was met and the inform consent was obtained. They were followed for 56 weeks including visits at 4, 12, 26, 39, and 52 weeks post-treatment for the safety and effectiveness evaluation. After complete 52-week visit, subjects would received HYAJOINT Plus on the target knee. These subjects were followed for 4 weeks to assess the safety of repeat treatment or cross reactions of the use from three-injections to single-injection hyaluronan treatment. The primary endpoints were the incidence of any adverse events during the study, as well as the objective assessment of pain visual analog scale at baseline and every visit.

Official Title
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Safety and Effectiveness of HYAJOINT Plus Synovial Fluid Supplement for the Treatment of Knee Osteoarthritis Pain

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: HYAJOINT Plus
* Device: Hyalgan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic knee osteoarthritis for at least 6 months despite nonoperative treatment and/or physical therapy Average knee pain score ≧ 30 mm on a 100-mm VAS Kellgren-Lawrence grade 2 or 3 knee osteoarthritis based on radiographs taken within previous 6 months 18 If the VAS pain score of the contralateral knee with radiographic evidence of bilateral knee osteoarthritis was < 30 mm Exclusion Criteria: Hip OA Kellgren-Lawrence grade 4 on target knee Clinical apparent active symptoms like infections Intra-articular injections of hyaluronan within the past 6 months Previous orthopaedic surgery on spine or lower limb Intra-articular injections of steroid type drugs within the past 3 months Diagnosed as Lupus erythematosus, Rheumatoid arthritis, Hemiparesis, Neoplasm or received hemodialysis Known allergy to avian proteins or hyaluronic acid products Women ascertained or suspected pregnancy or lactating

Ages Eligible for Study
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Minimum Age: 35 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HYAJOINT Plus group<br>The HYAJOINT Plus group received one intraarticular injection of 3 ml HYAJOINT Plus and be followed for 52 weeks. A single injection of HYAJOINT Plus was performed if criteria was met at 52 weeks, and a 4-weeks follow-up of adverse events was conducted. | Device: HYAJOINT Plus<br>* Single-injection, 60 mg / 3 ml (2%) cross-linked hyaluronan<br>|
| Active Comparator: Hyalgan group<br>The Hyalgan group received intraarticular injection of 2 ml Hyalgan for three continuously weeks and be followed for 52 weeks. A single injection of HYAJOINT Plus was performed if criteria was met at 52 weeks, and a 4-weeks follow-up of adverse events was conducted. | Device: Hyalgan<br>* Three-injection, 20 mg / 2 ml (1%) linear hyaluronan<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 a Visual analog scale score for pain. The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain'. | Baseline, 1, 3, 6, 9 and 12 months post-injection | 
| The reported adverse events | Any 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. | 1, 3, 6, 9 and 12 months post-injection | 

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. | Baseline, 1, 3, 6, 9 and 12 months post-injection | 
| VAS stiffness score | The change from baseline in the Visual analog scale score for stiffness. The VAS scale uses a 100 mm line labelled at '0' with 'no stiffness' and '100' with 'worst stiffness'. | Baseline, 1, 3, 6, 9 and 12 months post-injection | 
| Timed Up-and-Go test (TUG) | A simple measurement of time in seconds for a subject to rise from an armchair, walk 3 meters, turn around, walk back to the chair, and sit down. | Baseline, 1, 3, 6, 9 and 12 months post-injection | 
| VAS satisfaction score | Patients rate their treatment satisfaction based on a 100 mm VAS. The VAS scale uses a 100 mm line labelled at '0' with 'least satisfaction' and '100' with 'highest satisfaction'. | 1, 3, 6, 9 and 12 months post-injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyaluronan, synovial fluid supplement