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

NCT03643588 | Completed

• 1 other identifier: RDCT-CHP
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis, Knee

Keywords

Hyaluronan; synovial fluid supplement

Outcome Measures

Primary Outcomes (2)

• VAS pain score

  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'.

  Baseline, 1, 3, 6, 9 and 12 months post-injection

• The reported adverse events

  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.

  1, 3, 6, 9 and 12 months post-injection

Secondary Outcomes (4)

• WOMAC, Likert Scale

  Baseline, 1, 3, 6, 9 and 12 months post-injection

• VAS stiffness score

  Baseline, 1, 3, 6, 9 and 12 months post-injection

• Timed Up-and-Go test (TUG)

  Baseline, 1, 3, 6, 9 and 12 months post-injection

• VAS satisfaction score

  1, 3, 6, 9 and 12 months post-injection

Study Arms (2)

HYAJOINT Plus group

EXPERIMENTAL

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.

Device: HYAJOINT Plus

Hyalgan group

ACTIVE COMPARATOR

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.

Device: Hyalgan

Interventions

HYAJOINT Plus DEVICE

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

HYAJOINT Plus group

Hyalgan DEVICE

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

Hyalgan group

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SciVision Biotech Inc.: lead

Related Publications (1)

• 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.

  PMID: 34162365 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 23, 2018
• Study Start: September 4, 2015
• Primary Completion: September 19, 2016
• Study Completion: April 12, 2017
• Last Updated: August 24, 2018

Record last verified: 2018-08