Safety and Effectiveness of Monovisc® Injection for Osteoarthritis of the Knee
- Conditions
- Osteoarthritis
- Interventions
- Device: Monovisc®Other: Saline
- Registration Number
- NCT00653432
- Lead Sponsor
- Anika Therapeutics, Inc.
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 369
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Monovisc® Monovisc® Injectable Hyaluronic Acid Gel Saline Saline 0.9% Sterile Saline
- Primary Outcome Measures
Name Time Method Percentage of Subjects Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score (ITT) >=40% and 15 mm From Baseline Through 12 Weeks 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.
- Secondary Outcome Measures
Name Time Method Evaluator Global Assessment Change From Baseline Through Week 12 (ITT) 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.
WOMAC Physical Function Score Change From Baseline Through Week 12 (ITT) 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.
Patient Global Assessment Change From Baseline Through Week 12 (ITT) 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.
Range of Motion Change From Baseline Through Week 12 (ITT) 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.
Trial Locations
- Locations (31)
Novara Clinical Research
🇺🇸Mesa, Arizona, United States
Intermountain Research Center
🇺🇸Boise, Idaho, United States
Physician Research Collaboration
🇺🇸Lincoln, Nebraska, United States
Arthritis Center of Reno
🇺🇸Reno, Nevada, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Illinois Bone & Joint Institute
🇺🇸Morton Grove, Illinois, United States
San Diego Arthritis Medical Clinic
🇺🇸San Diego, California, United States
Summit Clinical Research
🇺🇸Aurora, Colorado, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Tampa Medical Clinic
🇺🇸Tampa, Florida, United States
Clinical Research Consultants
🇺🇸Hoover, Alabama, United States
Tuscon Orthopaedic Institute
🇺🇸Tucson, Arizona, United States
Providence Clinical Research
🇺🇸Burbank, California, United States
Boulder Medical Center
🇺🇸Boulder, Colorado, United States
Colorado Orthopedic Consultants
🇺🇸Englewood, Colorado, United States
Resurgens Orthopedics
🇺🇸Cumming, Georgia, United States
Community Research Foundation
🇺🇸Miami, Florida, United States
Plancher Orthopaedic and Sports Medicine
🇺🇸Cos Cob, Connecticut, United States
Wellborn Clinic
🇺🇸Evansville, Indiana, United States
David Neustadt PSC
🇺🇸Louisville, Kentucky, United States
Center for Rheumatology and Bone Research
🇺🇸Wheaton, Maryland, United States
Great Lakes Research Group
🇺🇸Bay City, Michigan, United States
Western Montana Clinic
🇺🇸Missoula, Montana, United States
Arthritis, Rheumatic & Back Disease Associates
🇺🇸Voorhees, New Jersey, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
The Arthritis Group
🇺🇸Philadelphia, Pennsylvania, United States
Clinical Research Center of Reading
🇺🇸West Reading, Pennsylvania, United States
Brian Gunnlaugson, MD
🇺🇸Johnstown, Pennsylvania, United States
SCRI
🇺🇸Germantown, Tennessee, United States
Valley Orthopedic Clinic
🇺🇸Harlingen, Texas, United States
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada