AzTrials
AzTrials

OsteoarthritisNCT00653432

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

A study testing Monovisc® and Saline in people with Osteoarthritis, run by Anika Therapeutics, Inc. at 31 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 35 to 75 years
Conditions the study is for
Osteoarthritis
What is being tested?
Monovisc® and Saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
369 participants
Where
31 sitesin 2 countries
Study dates
Jan 2008to Feb 2010
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

31 sites in 2 countries.

31 sites in 2 countries

United States30 sites

  • Summit Clinical Research

    Aurora, Colorado, 80013

  • Great Lakes Research Group

    Bay City, Michigan, 48706

  • Intermountain Research Center

    Boise, Idaho, 83702

  • Boulder Medical Center

    Boulder, Colorado, 80304

  • Providence Clinical Research

    Burbank, California, 91505

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Plancher Orthopaedic and Sports Medicine

    Cos Cob, Connecticut, 06807

  • Resurgens Orthopedics

    Cumming, Georgia, 30041

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • Colorado Orthopedic Consultants

    Englewood, Colorado, 80110

  • Wellborn Clinic

    Evansville, Indiana, 47713

  • SCRI

    Germantown, Tennessee, 38138

  • Valley Orthopedic Clinic

    Harlingen, Texas, 78550

  • Clinical Research Consultants

    Hoover, Alabama, 35216

  • Brian Gunnlaugson, MD

    Johnstown, Pennsylvania, 15901

  • Physician Research Collaboration

    Lincoln, Nebraska, 68516

  • David Neustadt PSC

    Louisville, Kentucky, 40202

  • Novara Clinical Research

    Mesa, Arizona, 85206

  • Community Research Foundation

    Miami, Florida, 33155

  • Western Montana Clinic

    Missoula, Montana, 59802

  • Illinois Bone & Joint Institute

    Morton Grove, Illinois, 60053

  • The Arthritis Group

    Philadelphia, Pennsylvania, 19152

  • Arizona Research Center

    Phoenix, Arizona, 85023

  • Arthritis Center of Reno

    Reno, Nevada, 89502

  • San Diego Arthritis Medical Clinic

    San Diego, California, 92108

  • Tampa Medical Clinic

    Tampa, Florida, 33614

  • Tuscon Orthopaedic Institute

    Tucson, Arizona, 85712

  • Arthritis, Rheumatic & Back Disease Associates

    Voorhees Township, New Jersey, 08043

  • Clinical Research Center of Reading

    West Reading, Pennsylvania, 19611

  • Center for Rheumatology and Bone Research

    Wheaton, Maryland, 20902

Other trials in United States

Canada1 site

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Conditions
Osteoarthritis
Being tested
Monovisc®, Saline
Keywords
Monovisc®, Hyaluronic Acid Gel, Injection, Knee
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Monovisc®Device

    Also called Sodium Hyaluronate, Hyaluronic Acid Gel

    Intra-articular injection

  • SalineOther

    0.9% Sterile Saline

Study groups in NCT00653432
Study groupRoleWhat they receive
Monovisc®ExperimentalInjectable Hyaluronic Acid Gel
Receives: Device: Monovisc®
SalinePlacebo comparator0.9% Sterile Saline
Receives: Other: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Subjects Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score (ITT) >=40% and 15 mm From Baseline Through 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.

    Measured: 12 Weeks

Secondary outcomes (4)

  1. Evaluator Global Assessment Change From Baseline Through Week 12 (ITT)

    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.

    Measured: 12 Weeks

  2. Patient Global Assessment Change From Baseline Through Week 12 (ITT)

    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.

    Measured: 12 Weeks

  3. Range of Motion Change From Baseline Through Week 12 (ITT)

    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.

    Measured: 12 Weeks

  4. WOMAC Physical Function Score Change From Baseline Through Week 12 (ITT)

    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.

    Measured: 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionDec 2009
  4. Study completionFeb 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
369 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00653432
Sponsor's protocol ID
Monovisc-0702
Status last verified
Jun 2023
First submitted
5 Mar 2008
Last updated
11 Jul 2023
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Monovisc® and Saline in people with Osteoarthritis, run by Anika Therapeutics, Inc. at 31 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00653432.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in