Clinical trial NCT03643588: The Comparison of HYAJOINT Plus and Hyalgan Hyaluronan Supplement for Knee Osteoarthritis Pain
Official title: Safety and Effectiveness of HYAJOINT Plus Synovial Fluid Supplement for the Treatment of Knee Osteoarthritis Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Hyaluronan
synovial fluid supplement
Lead sponsor: SciVision Biotech Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-23
Enrollment: 140
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: VAS pain score
timeFrame: Baseline, 1, 3, 6, 9 and 12 months post-injection
measure: The reported adverse events
timeFrame: 1, 3, 6, 9 and 12 months post-injection
Secondary outcomes:
measure: WOMAC, Likert Scale
timeFrame: Baseline, 1, 3, 6, 9 and 12 months post-injection
measure: VAS stiffness score
timeFrame: Baseline, 1, 3, 6, 9 and 12 months post-injection
measure: Timed Up-and-Go test (TUG)
timeFrame: Baseline, 1, 3, 6, 9 and 12 months post-injection
measure: VAS satisfaction score
timeFrame: 1, 3, 6, 9 and 12 months post-injection
Other outcomes:
Locations:
Study officials:
References:
citation: Huang TL, Tsai CH. Safety and efficacy of single CHAP Hyaluronan injection versus three injections of linear Hyaluronan in pain relief for knee osteoarthritis: a prospective, 52-week follow-up, randomized, evaluator-blinded study. BMC Musculoskelet Disord. 2021 Jun 23;22(1):572. doi: 10.1186/s12891-021-04467-3.