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

Safety and Effectiveness of HYAJOINT Plus Synovial Fluid Supplement for the Treatment of Knee Osteoarthritis Pain

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: HYAJOINT Plus; Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
WOMAC, Likert Scale	a 24-item questionnaire with 3 subscales measuring pain, stiffness, and physical function. Total score is 96 and lower scores indicate better outcomes.	Baseline, 1, 3, 6, 9 and 12 months post-injection
VAS stiffness score	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'.	Baseline, 1, 3, 6, 9 and 12 months post-injection
Timed Up-and-Go test (TUG)	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.	Baseline, 1, 3, 6, 9 and 12 months post-injection
VAS satisfaction score	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'.	1, 3, 6, 9 and 12 months post-injection

Collaborators and Investigators

• Sponsor: SciVision Biotech Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2015
• Primary Completion (Actual): September 19, 2016
• Study Completion (Actual): April 12, 2017

Study Registration Dates

• First Submitted: August 21, 2018
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (Actual): August 23, 2018

Study Record Updates

• Last Update Posted (Actual): August 24, 2018
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Hyaluronan; synovial fluid supplement
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: RDCT-CHP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No