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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03643588
• Other study ID #: RDCT-CHP
• Status: Completed
• Phase: N/A
• Start date: September 4, 2015
• Est. completion date: April 12, 2017

Study information

• Verified date: August 2018
• Source: SciVision Biotech Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: April 12, 2017
• Est. primary completion date: September 19, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• HYAJOINT Plus
Single-injection, 60 mg / 3 ml (2%) cross-linked hyaluronan
• Hyalgan
Three-injection, 20 mg / 2 ml (1%) linear hyaluronan

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SciVision Biotech Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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