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

SciVision Biotech

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Device: Hyalgan; Device: HYAJOINT Plus

Study type: Interventional

Funder types: Industry

Identifiers

NCT03643588

RDCT-CHP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 35 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

HYAJOINT Plus group

Experimental group

Description:

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.

Treatment:

Device: HYAJOINT Plus

Hyalgan group

Active Comparator group

Description:

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.

Treatment:

Device: Hyalgan