Comparing One Intraarticular Injection of a Novel HYAJOINT Plus With Synvisc-One for the Treatment of Knee OA

Comparing Efficacy and Safety of a Single Intraarticular Injection of a Novel Crosslinked Hyaluronic Acid (HYAJOINT Plus) With Synvisc-One for the Treatment of Knee Osteoarthritis: A Randomized-Controlled, Double-Blind Trial

Viscosupplementation has been widely used for the treatment of knee osteoarthritis (OA). There is no well controlled trial comparing one injection regimen of HA for the treatment of knee OA. The purpose of this study was to compare the efficacy and safety of one intraarticular injection of a novel crosslinked HA (HYAJOINT Plus) with Synvisc-One for the treatment of knee OA.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: HYAJOINT Plus; Device: Synvisc-One

Detailed Description

In a prospective, randomized controlled, double-blind trial with 6-month follow up, patients with knee OA (Kellgren-Lawrence grade 2 or 3) were randomized to receive one intraarticular injection of 3 ml HYAJOINT Plus (microbial fermented HA, 20 mg/ml) (N=66) or 6 ml Synvisc-One (avian derived HA, 8 mg/ml) (N=66). The primary outcome was change in the visual analog scale (VAS) pain (0-100mm) over 6 months. Secondary outcomes included The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lequesne index, Timed Up-and-Go test (TUG), single leg stance test (SLS), use of rescue analgesics and patient satisfaction.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 813
    • Kaohsiung Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• symptomatic knee OA with pain for at least 6 months, despite conservative treatment such as analgesics, NSAIDs and/or physical therapy

• average pain on knee movement of 30 mm or greater on a 100-mm VAS

  • grade 2 or 3 knee OA according to the Kellgren-Lawrence grading system based on radiographs taken within the previous 6 months
  • Radiological evidence of bilateral knee OA was accepted if global pain VAS in the contralateral knee was less than 30 mm.

Exclusion Criteria:

• previous orthopedic surgery on the spine or lower limbs
• disabling OA of either hip or foot
• knee instability, clinical apparent joint effusion or marked valgus/varus deformity
• known allergy to avian proteins or HA products
• women ascertained or suspected pregnancy or lactating
• intraarticular injections within the past 6 months
• infections or skin diseases around the target knee
• any specific medical conditions (rheumatoid arthritis, hemiparesis, neoplasm, etc.) that would interfere with the assessments

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the HYAJOINT Plus group; the HYAJOINT Plus group received one intraarticular injection of 3 ml HYAJOINT Plus (2% microbial fermented HA, 20 mg/ml).	Device: HYAJOINT Plus; The patients in the HYAJOINT Plus group received one intraarticular injection of 3 ml HYAJOINT Plus (2% microbial fermented HA, 20 mg/ml).; Other Names: Hyaluronic acid
Active Comparator: The Synvisc-One group; The Synvisc-One group received one injection of 6 ml Synvisc-One (0.8% avian derived HA, 8 mg/ml).	Device: Synvisc-One; The Synvisc-One group received one injection of 6 ml Synvisc-One (0.8% avian derived HA, 8 mg/ml).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS pain score	the change from baseline in the VAS pain score over 6 months.	at 1, 3 and 6 months postinjection

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.	at 1, 3 and 6 months postinjection
Lequesne index	Maximal score is 24 and higher scores represent worse function.	at 1, 3 and 6 months postinjection
Timed Up-and-Go test (TUG)	a simple measurement of time in seconds for a person to rise from an armchair, walk 3 meters, turn around, walk back to the chair, and sit down	at 1, 3 and 6 months postinjection
Single-leg stance test (SLS)	by raising one foot up without touching it to the supported lower extremity with target knee OA and maintain balance for as long as possible.	at 1, 3 and 6 months postinjection
satisfaction based on a 100 mm VAS	Patients were asked to rate their treatment satisfaction compared to the preinjection condition, based on a 100 mm VAS	at 1, 3 and 6 months postinjection
The reported adverse events	based on 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	at 1 week (safety records via phone call), 1, 3 and 6 months after the injection

Collaborators and Investigators

• Sponsor: Kaohsiung Veterans General Hospital.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: February 11, 2016
• First Submitted That Met QC Criteria: February 14, 2016
• First Posted (Estimate): February 19, 2016

Study Record Updates

• Last Update Posted (Estimate): February 19, 2016
• Last Update Submitted That Met QC Criteria: February 14, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Viscosupplementation; Knee osteoarthritis; Hyaluronic acid
• 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; Hylan
• Other Study ID Numbers: VGHKS14-CT8-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No