NCT02686047

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P75+ for phase_2 knee-osteoarthritis

Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_2 knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 19, 2016

Completed
Last Updated

February 19, 2016

Status Verified

February 1, 2016

Enrollment Period

11 months

First QC Date

February 11, 2016

Last Update Submit

February 14, 2016

Conditions

Knee Osteoarthritis

Keywords

Knee osteoarthritisHyaluronic acidViscosupplementation

Outcome Measures

Primary Outcomes (1)

  • VAS pain score

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

    at 1, 3 and 6 months postinjection

Secondary Outcomes (6)

  • WOMAC, Likert Scale

    at 1, 3 and 6 months postinjection

  • Lequesne index

    at 1, 3 and 6 months postinjection

  • Timed Up-and-Go test (TUG)

    at 1, 3 and 6 months postinjection

  • Single-leg stance test (SLS)

    at 1, 3 and 6 months postinjection

  • satisfaction based on a 100 mm VAS

    at 1, 3 and 6 months postinjection

  • +1 more secondary outcomes

Study Arms (2)

the HYAJOINT Plus group

EXPERIMENTAL

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

Device: HYAJOINT Plus

The Synvisc-One group

ACTIVE COMPARATOR

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

Device: Synvisc-One

Interventions

HYAJOINT PlusDEVICE

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

Also known as: Hyaluronic acid
the HYAJOINT Plus group
Synvisc-OneDEVICE

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

The Synvisc-One group

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 11, 2016

First Posted

February 19, 2016

Study Start

September 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

February 19, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)