The Comparison of HYAJOINT Plus and Hyalgan Hyaluronan Supplement for Knee Osteoarthritis Pain
- Conditions
- Osteoarthritis, Knee
- Interventions
- Device: HYAJOINT PlusDevice: Hyalgan
- Registration Number
- NCT03643588
- Lead Sponsor
- SciVision Biotech Inc.
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HYAJOINT Plus group HYAJOINT Plus 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. Hyalgan group Hyalgan 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.
- Primary Outcome Measures
Name Time Method The reported adverse events 1, 3, 6, 9 and 12 months post-injection 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.
VAS pain score Baseline, 1, 3, 6, 9 and 12 months post-injection 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'.
- Secondary Outcome Measures
Name Time Method WOMAC, Likert Scale Baseline, 1, 3, 6, 9 and 12 months post-injection a 24-item questionnaire with 3 subscales measuring pain, stiffness, and physical function. Total score is 96 and lower scores indicate better outcomes.
VAS satisfaction score 1, 3, 6, 9 and 12 months post-injection 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'.
VAS stiffness score Baseline, 1, 3, 6, 9 and 12 months post-injection 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'.
Timed Up-and-Go test (TUG) Baseline, 1, 3, 6, 9 and 12 months post-injection 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.