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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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the HYAJOINT Plus group

the HYAJOINT Plus group received one intraarticular injection of 3 ml HYAJOINT Plus (2% microbial fermented HA, 20 mg/ml).

Group Type EXPERIMENTAL

HYAJOINT Plus

Intervention Type DEVICE

The patients in the HYAJOINT Plus group received one intraarticular injection of 3 ml HYAJOINT Plus (2% microbial fermented HA, 20 mg/ml).

The Synvisc-One group

The Synvisc-One group received one injection of 6 ml Synvisc-One (0.8% avian derived HA, 8 mg/ml).

Group Type ACTIVE_COMPARATOR

Synvisc-One

Intervention Type DEVICE

The Synvisc-One group received one injection of 6 ml Synvisc-One (0.8% avian derived HA, 8 mg/ml).

Interventions

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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).

Intervention Type DEVICE

Synvisc-One

The Synvisc-One group received one injection of 6 ml Synvisc-One (0.8% avian derived HA, 8 mg/ml).

Intervention Type DEVICE

Other Intervention Names

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Hyaluronic acid

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No