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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
369

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Anika Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2008

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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