search
Back to results

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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
HYAJOINT Plus
Synvisc-One
Sponsored by
Kaohsiung Veterans General Hospital.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee osteoarthritis, Hyaluronic acid, Viscosupplementation

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaohsiung Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

the HYAJOINT Plus group

The Synvisc-One group

Arm Description

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

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

Outcomes

Primary Outcome Measures

VAS pain score
the change from baseline in the VAS pain score over 6 months.

Secondary Outcome Measures

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.
Lequesne index
Maximal score is 24 and higher scores represent worse function.
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
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.
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
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

Full Information

First Posted
February 11, 2016
Last Updated
February 14, 2016
Sponsor
Kaohsiung Veterans General Hospital.
search

1. Study Identification

Unique Protocol Identification Number
NCT02686047
Brief Title
Comparing One Intraarticular Injection of a Novel HYAJOINT Plus With Synvisc-One for the Treatment of Knee OA
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Veterans General Hospital.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee osteoarthritis, Hyaluronic acid, Viscosupplementation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the HYAJOINT Plus group
Arm Type
Experimental
Arm Description
the HYAJOINT Plus group received one intraarticular injection of 3 ml HYAJOINT Plus (2% microbial fermented HA, 20 mg/ml).
Arm Title
The Synvisc-One group
Arm Type
Active Comparator
Arm Description
The Synvisc-One group received one injection of 6 ml Synvisc-One (0.8% avian derived HA, 8 mg/ml).
Intervention Type
Device
Intervention Name(s)
HYAJOINT Plus
Other Intervention Name(s)
Hyaluronic acid
Intervention Description
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
Intervention Name(s)
Synvisc-One
Intervention Description
The Synvisc-One group received one injection of 6 ml Synvisc-One (0.8% avian derived HA, 8 mg/ml).
Primary Outcome Measure Information:
Title
VAS pain score
Description
the change from baseline in the VAS pain score over 6 months.
Time Frame
at 1, 3 and 6 months postinjection
Secondary Outcome Measure Information:
Title
WOMAC, Likert Scale
Description
a 24-item questionnaire with 3 subscales measuring pain, stiffness, and physical function. Total score is 96 and lower scores indicate better outcomes.
Time Frame
at 1, 3 and 6 months postinjection
Title
Lequesne index
Description
Maximal score is 24 and higher scores represent worse function.
Time Frame
at 1, 3 and 6 months postinjection
Title
Timed Up-and-Go test (TUG)
Description
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
Time Frame
at 1, 3 and 6 months postinjection
Title
Single-leg stance test (SLS)
Description
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.
Time Frame
at 1, 3 and 6 months postinjection
Title
satisfaction based on a 100 mm VAS
Description
Patients were asked to rate their treatment satisfaction compared to the preinjection condition, based on a 100 mm VAS
Time Frame
at 1, 3 and 6 months postinjection
Title
The reported adverse events
Description
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
Time Frame
at 1 week (safety records via phone call), 1, 3 and 6 months after the injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs