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

• ClinicalTrials.gov Identifier: NCT03643588
• Recruitment Status: Completed
• First Posted: August 23, 2018
• Last Update Posted: August 24, 2018
• Sponsor: SciVision Biotech Inc.
• Information provided by (Responsible Party): SciVision Biotech Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis, Knee	Device: HYAJOINT Plus; Device: Hyalgan	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Safety and Effectiveness of HYAJOINT Plus Synovial Fluid Supplement for the Treatment of Knee Osteoarthritis Pain
• Actual Study Start Date: September 4, 2015
• Actual Primary Completion Date: September 19, 2016
• Actual Study Completion Date: April 12, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Device: HYAJOINT Plus; Single-injection, 60 mg / 3 ml (2%) cross-linked hyaluronan
Active Comparator: 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.	Device: Hyalgan; Three-injection, 20 mg / 2 ml (1%) linear hyaluronan

Outcome Measures

Primary Outcome Measures :

1. VAS pain score [ Time Frame: 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'.
2. The reported adverse events [ Time Frame: 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 Outcome Measures :

1. WOMAC, Likert Scale [ Time Frame: 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.
2. VAS stiffness score [ Time Frame: 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'.
3. Timed Up-and-Go test (TUG) [ Time Frame: 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.
4. VAS satisfaction score [ Time Frame: 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'.

Eligibility Criteria

• Ages Eligible for Study: 35 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: SciVision Biotech Inc.
• ClinicalTrials.gov Identifier: NCT03643588
• Other Study ID Numbers: RDCT-CHP
• First Posted: August 23, 2018
• Last Update Posted: August 24, 2018
• Last Verified: August 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by SciVision Biotech Inc.:

Hyaluronan; synovial fluid supplement

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Hyaluronic Acid; Adjuvants, Immunologic; Immunologic Factors; Physiological Effects of Drugs; Viscosupplements; Protective Agents