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

NCT00653432 | Completed Results

• 1 other identifier: Monovisc-0702
• Study Type: interventional
• Target: 369
• Locations: 2 countries
• Sites: 31

Brief 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.

Conditions

Osteoarthritis

Keywords

Monovisc®; Hyaluronic Acid Gel; Injection; Knee

Outcome Measures

Primary Outcomes (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.

  12 Weeks

Secondary Outcomes (4)

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

  12 Weeks

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

  12 Weeks

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

  12 Weeks

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

  12 Weeks

Study Arms (2)

Monovisc®

EXPERIMENTAL

Injectable Hyaluronic Acid Gel

Device: Monovisc®

Saline

PLACEBO COMPARATOR

0.9% Sterile Saline

Other: Saline

Interventions

Monovisc® DEVICE

Intra-articular injection

Also known as: Sodium Hyaluronate, Hyaluronic Acid Gel

Monovisc®

Saline OTHER

0.9% Sterile Saline

Saline

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anika Therapeutics, Inc.: lead

Study Sites (31)

Clinical Research Consultants

Hoover, Alabama, 35216, United States

Location

Novara Clinical Research

Mesa, Arizona, 85206, United States

Location

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

Tuscon Orthopaedic Institute

Tucson, Arizona, 85712, United States

Location

Providence Clinical Research

Burbank, California, 91505, United States

Location

San Diego Arthritis Medical Clinic

San Diego, California, 92108, United States

Location

Summit Clinical Research

Aurora, Colorado, 80013, United States

Location

Boulder Medical Center

Boulder, Colorado, 80304, United States

Location

Colorado Orthopedic Consultants

Englewood, Colorado, 80110, United States

Location

Plancher Orthopaedic and Sports Medicine

Cos Cob, Connecticut, 06807, United States

Location

Community Research Foundation

Miami, Florida, 33155, United States

Location

Tampa Medical Clinic

Tampa, Florida, 33614, United States

Location

Resurgens Orthopedics

Cumming, Georgia, 30041, United States

Location

Intermountain Research Center

Boise, Idaho, 83702, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Illinois Bone & Joint Institute

Morton Grove, Illinois, 60053, United States

Location

Wellborn Clinic

Evansville, Indiana, 47713, United States

Location

David Neustadt PSC

Louisville, Kentucky, 40202, United States

Location

Center for Rheumatology and Bone Research

Wheaton, Maryland, 20902, United States

Location

Great Lakes Research Group

Bay City, Michigan, 48706, United States

Location

Western Montana Clinic

Missoula, Montana, 59802, United States

Location

Physician Research Collaboration

Lincoln, Nebraska, 68516, United States

Location

Arthritis Center of Reno

Reno, Nevada, 89502, United States

Location

Arthritis, Rheumatic & Back Disease Associates

Voorhees Township, New Jersey, 08043, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Brian Gunnlaugson, MD

Johnstown, Pennsylvania, 15901, United States

Location

The Arthritis Group

Philadelphia, Pennsylvania, 19152, United States

Location

Clinical Research Center of Reading

West Reading, Pennsylvania, 19611, United States

Location

SCRI

Germantown, Tennessee, 38138, United States

Location

Valley Orthopedic Clinic

Harlingen, Texas, 78550, United States

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Kara Mezger, Exec Director Clinical Affairs
• Organization: Anika Therapeutics, Inc.

kmezger@anika.com

781.457.9000

Study Officials

• Stephen Schmitz, MD

  Prometrika, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2008
• First Posted: April 7, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: February 1, 2010
• Last Updated: July 11, 2023
• Results First Posted: September 1, 2020

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (30); CA (1)