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

NCT ID: NCT03643588

Last Updated: 2018-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-04
• Study Completion Date: 2017-04-12

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

HYAJOINT Plus group

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.

Group Type: EXPERIMENTAL

HYAJOINT Plus

Intervention Type: DEVICE

Single-injection, 60 mg / 3 ml (2%) cross-linked hyaluronan

Hyalgan group

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.

Group Type: ACTIVE_COMPARATOR

Hyalgan

Intervention Type: DEVICE

Three-injection, 20 mg / 2 ml (1%) linear hyaluronan

Interventions

HYAJOINT Plus

Single-injection, 60 mg / 3 ml (2%) cross-linked hyaluronan

Intervention Type: DEVICE

Hyalgan

Three-injection, 20 mg / 2 ml (1%) linear hyaluronan

Intervention Type: DEVICE

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SciVision Biotech Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 34162365 (View on PubMed)

Other Identifiers

RDCT-CHP

Identifier Type: -

Identifier Source: org_study_id