Non-Inferiority Study Comparing 3 Weekly Injections of SUPARTZ® vs 3 Weekly Injections of Euflexxa® for Knee OA

February 12, 2021 updated by: Bioventus LLC

Multicenter, Randomized, Double-Blind, Parallel Controlled Non-Inferiority Clinical Trial Comparing 3 Weekly Intra-articular Injections of SUPARTZ® vs 3 Weekly Intra-articular Injections of Euflexxa® for Treatment of Knee OA

The purpose of this study is to demonstrate non-inferiority of three weekly intra-articular injections of SUPARTZ to three weekly intra-articular injections of Euflexxa for the relief of knee OA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to demonstrate non-inferiority of three weekly intra-articular injections of SUPARTZ to three weekly intra-articular injections of Euflexxa for the relief of knee joint pain in subjects with osteoarthritis (OA) of the knee as measured by the VAS (0-100 mm) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale score Change from Baseline (CFB) over Weeks 3, 6, 12.

Safety will be accessed by recording adverse events, concomitant medications, physical examinations, and vital signs.

Study Type

Interventional

Enrollment (Actual)

421

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27704
        • Triangle Orthopaedic Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical evidence of symptomatic osteoarthritis of the study knee as classified according to Altman criteria.
  • Symptoms in study knee for at least one year prior to the screening visit
  • Verified OA of the study knee of Grade 2 or 3 according to a modification of the grading system of Kellgren-Lawrence (K-L) radiographic severity.
  • Willingness to discontinue NSAIDs (systemic and topical) and non-acetaminophen analgesic use seven days or five half-lives prior to the first injection and throughout the study.

Exclusion Criteria:

  • Inability to perform a 50 foot walk test.
  • Subjects with rheumatoid arthritis, joint infection, other inflammatory and metabolic arthritis, Lupus or dermatologic disorder or skin conditions in close proximity to study knee that would preclude safe intra-articular injections.
  • Prior hyaluronic acid injections into the study knee within six months of the screening visit.
  • Intra-articular or intra-muscular steroid injections within three months of the screening visit or during study participation. Oral corticosteroids within four weeks of the screening visit or during study participation.
  • History of surgical treatment to the study knee or arthroscopic intervention within three months prior to the screening visit.
  • Clinically apparent tense effusion of the study knee on examination determined by either a positive bulge sign or positive ballottement of the patella (patellar tap).
  • Subjects with clinically diagnosed symptomatic OA of the hip.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Euflexxa
Euflexxa® (hyaluronic acid of bacterial origin)
Device: Euflexxa
Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
Experimental: Supartz
SUPARTZ® (hyaluronic acid of avian origin)
Device: Supartz
Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC VAS (0:None -100:Extreme) Pain Subscale Score Change From Baseline
Time Frame: Change from Baseline (CFB) over Weeks 3, 6, and 12
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) 0-100mm Pain subscale score Change from Baseline (CFB). Over weeks 3, 6, and 12 least square mean difference in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (0mm:None - 100mm:Extreme) pain subscale score Change from Baseline (CFB). A single estimate of least squares mean was calculated using data from baseline, weeks 3, 6, and 12.
Change from Baseline (CFB) over Weeks 3, 6, and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bioventus LLC

Collaborators

Seikagaku Corporation

Investigators

  • Principal Investigator: Vibeke Strand, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

April 3, 2014

First Submitted That Met QC Criteria

April 9, 2014

First Posted (Estimate)

April 10, 2014

Study Record Updates

Last Update Posted (Actual)

March 9, 2021

Last Update Submitted That Met QC Criteria

February 12, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13SUP301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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