Osteoarthritis, Knee
Conditions
Keywords
Hyaluronan, synovial fluid supplement
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.
Interventions
DEVICEHYAJOINT Plus
Single-injection, 60 mg / 3 ml (2%) cross-linked hyaluronan
DEVICEHyalgan
Three-injection, 20 mg / 2 ml (1%) linear hyaluronan
Sponsors
SciVision Biotech Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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'. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed