Safety and Effectiveness of Monovisc® Injection for Osteoarthritis of the Knee

June 21, 2023 updated by: Anika Therapeutics, Inc.

A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate to Provide Symptomatic Relief of Osteoarthritis of the Knee

The purpose of this study is to determine whether intra-articular injection of Monovisc® hyaluronic acid provides symptomatic relief of osteoarthritis of the knee.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This randomized, double-blind, placebo controlled prospective study will assess the safety and effectiveness of a single intra-articular injection of Monovisc® in providing symptomatic relief of pain caused by idiopathic osteoarthritis (OA) of the knee as compared to a placebo comparator injection of sterile saline.

Study Type

Interventional

Enrollment (Actual)

369

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
  • United States
    • Alabama
      • Hoover, Alabama, United States, 35216
        • Clinical Research Consultants
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Novara Clinical Research
      • Phoenix, Arizona, United States, 85023
        • Arizona Research Center
      • Tucson, Arizona, United States, 85712
        • Tuscon Orthopaedic Institute
    • California
      • Burbank, California, United States, 91505
        • Providence Clinical Research
      • San Diego, California, United States, 92108
        • San Diego Arthritis Medical Clinic
    • Colorado
      • Aurora, Colorado, United States, 80013
        • Summit Clinical Research
      • Boulder, Colorado, United States, 80304
        • Boulder Medical Center
      • Englewood, Colorado, United States, 80110
        • Colorado Orthopedic Consultants
    • Connecticut
      • Cos Cob, Connecticut, United States, 06807
        • Plancher Orthopaedic and Sports Medicine
    • Florida
      • Miami, Florida, United States, 33155
        • Community Research Foundation
      • Tampa, Florida, United States, 33614
        • Tampa Medical Clinic
    • Georgia
      • Cumming, Georgia, United States, 30041
        • Resurgens Orthopedics
    • Idaho
      • Boise, Idaho, United States, 83702
        • Intermountain Research Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Morton Grove, Illinois, United States, 60053
        • Illinois Bone & Joint Institute
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Wellborn Clinic
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • David Neustadt PSC
    • Maryland
      • Wheaton, Maryland, United States, 20902
        • Center for Rheumatology and Bone Research
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Great Lakes Research Group
    • Montana
      • Missoula, Montana, United States, 59802
        • Western Montana Clinic
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Physician Research Collaboration
    • Nevada
      • Reno, Nevada, United States, 89502
        • Arthritis Center of Reno
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Arthritis, Rheumatic & Back Disease Associates
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
      • Johnstown, Pennsylvania, United States, 15901
        • Brian Gunnlaugson, MD
      • Philadelphia, Pennsylvania, United States, 19152
        • The Arthritis Group
      • West Reading, Pennsylvania, United States, 19611
        • Clinical Research Center of Reading
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • SCRI
    • Texas
      • Harlingen, Texas, United States, 78550
        • Valley Orthopedic Clinic

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

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Main Inclusion Criteria:

  • Male or Female
  • Age 35 to 75 years
  • Body Mass Index (BMI) 20 to 40 kg/m2
  • Willing and able to provide informed consent
  • Willing to limit analgesic use to acetaminophen 7 days prior to and 12 weeks after injection
  • Not pregnant or lactating
  • Previous conservative treatment regimen for osteoarthritis (OA)
  • Diagnosis of idiopathic OA of the index knee
  • OA symptoms for >= 6 months
  • Index knee Kellgren-Lawrence (K-L) grade of II or III
  • Index knee Baseline Summed WOMAC Pain Score >= 200mm and < 400mm after NSAID washout
  • Contralateral Knee K-L grade 0, I or II
  • Contralateral Knee Baseline WOMAC Pain Score < 150mm after NSAID washout

Main Exclusion Criteria:

  • Joint disorders which could interfere with treatment effectiveness
  • Joint disorders which could interfere with study assessments
  • Arthroscopy of either knee within 3 months of screening
  • Open surgery of index knee within 12 months of screening
  • Open surgery of contralateral knee within 3 months of screening
  • Injection of Hyaluronic Acid (HA) in either knee within 6 months of screening
  • Injection of steroid in index knee within 3 months of screening
  • Any pre-treatment contraindication for injection or aspiration of the index knee, including cutaneous infection, intra-articular infection, knee deformity or condition which may jeopardize sterility or delivery of injection
  • Synovial fluid aspirate volume > 20 milliliters (mL)
  • Visual appearance of synovial fluid that contraindicates injection
  • Index knee range of motion < 90 degrees
  • Subject participation in other research study within 30 days of screening
  • Subject unwilling to maintain active lifestyle, exercise program and body weight similar to that during 3 months prior to screening for duration of study
  • Unwilling to maintain constant dosage of oral glucosamine or chondroitin sulfate for duration of study, if applicable
  • Other medication or treatments that could interfere with study injection or assessments
  • Allergy to gram positive bacterial products or intolerance of acetaminophen
  • Active fibromyalgia
  • Peripheral neuropathy severe enough to interfere with evaluation of either knee
  • Vascular insufficiency severe enough to interfere with evaluation of the subject
  • Hemiparesis involving either lower extremity
  • Systemic bleeding disorder
  • Other conditions which may adversely affect the success of the procedure

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
Experimental: Monovisc®
Injectable Hyaluronic Acid Gel
Device: Monovisc®
Intra-articular injection
Other Names:
  • Sodium Hyaluronate
  • Hyaluronic Acid Gel
Placebo Comparator: Saline
0.9% Sterile Saline
Other: Saline
0.9% Sterile Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score (ITT) >=40% and 15 mm From Baseline Through 12 Weeks
Time Frame: 12 Weeks
The primary endpoint measures the percentage of subjects (Monovisc vs. saline) who achieved >= a 40% improvement (reduction) in the WOMAC Pain Score and show at least 15 mm improvement (reduction) in the WOMAC Pain Score from baseline through 12 weeks. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score is a validated scale from 0 to 100 mm, where a higher score is equal to a higher pain level. The primary endpoint uses the ITT population that has data available for both baseline and 12 week time points.
12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluator Global Assessment Change From Baseline Through Week 12 (ITT)
Time Frame: 12 Weeks
Comparison of the change of the Evaluator Global Assessment from baseline through Week 12 between Monovisc and saline arms (ITT Population). The Evaluator Global Assessment is done by the Blinded Evaluator, and answers the question "Considering all the ways the osteoarthritis in the patient's index knee affect him/her, what is your assessment of how much the patient's knee is bothering him/her today?" The Evaluator Global Assessment is scored on a 0 to 100 mm Visual Analog Scale (VAS Scale), where a higher number means the patient is bothered to a higher degree. A negative number for the change from baseline indicates a reduction (improvement) in the assessment. The endpoint uses the ITT population that has data available for both baseline and 12 week time points.
12 Weeks
Patient Global Assessment Change From Baseline Through Week 12 (ITT)
Time Frame: 12 Weeks
Comparison of the change of the Patient Global Assessment from baseline through Week 12 between Monovisc and saline arms (ITT Population). The Patient Global Assessment is done by the patient, and answers the question "Considering all the ways the osteoarthritis in your study knee affects you, what is your assessment of how much your study knee is bothering you today?" The Patient Global Assessment is scored on a 0 to 100 mm Visual Analog Scale (VAS Scale), where a higher number means the patient is bothered to a higher degree. A negative number for the change from baseline indicates a reduction (improvement) in the assessment. The endpoint uses the ITT population that has data available for both baseline and 12 week time points.
12 Weeks
Range of Motion Change From Baseline Through Week 12 (ITT)
Time Frame: 12 Weeks
Comparison of the change of Range of Motion from baseline through Week 12 between Monovisc and saline arms (ITT Population). Range of motion is defined as the difference between flexion and extension in degrees where full extension range is 180 degrees. The endpoint uses the ITT population that has data available for both baseline and 12 week time points.
12 Weeks
WOMAC Physical Function Score Change From Baseline Through Week 12 (ITT)
Time Frame: 12 Weeks
This endpoint compares the change of the WOMAC Physical Function Score from baseline through Week 12 between Monovisc and saline arms (ITT Population). The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Score is a validated scale from 0 to 100 mm, where a higher score is equal to a higher degree of functional limitation. A negative number for the change from baseline indicates improvement in physical function. The ITT population includes subjects with data at baseline and 12 Week time points.
12 Weeks

Collaborators and Investigators

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

Sponsor

Anika Therapeutics, Inc.

Investigators

  • Study Director: Stephen Schmitz, MD, Prometrika, LLC

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

January 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

March 5, 2008

First Submitted That Met QC Criteria

April 2, 2008

First Posted (Estimated)

April 7, 2008

Study Record Updates

Last Update Posted (Actual)

July 11, 2023

Last Update Submitted That Met QC Criteria

June 21, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Monovisc-0702

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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