Clinical trial NCT00653432: Safety and Effectiveness of Monovisc® Injection for Osteoarthritis of the Knee
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Monovisc®
Hyaluronic Acid Gel
Injection
Knee
Lead sponsor: Anika Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-07
Enrollment: 369
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: 12 Weeks
Secondary outcomes:
measure: Evaluator Global Assessment Change From Baseline Through Week 12 (ITT)
timeFrame: 12 Weeks
measure: Patient Global Assessment Change From Baseline Through Week 12 (ITT)
timeFrame: 12 Weeks
measure: Range of Motion Change From Baseline Through Week 12 (ITT)
timeFrame: 12 Weeks
measure: WOMAC Physical Function Score Change From Baseline Through Week 12 (ITT)
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Hoover
country: United States
facility: Clinical Research Consultants
state: Alabama
city: Mesa
country: United States
facility: Novara Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Tucson
country: United States
facility: Tuscon Orthopaedic Institute
state: Arizona
city: Burbank
country: United States
facility: Providence Clinical Research
state: California
city: San Diego
country: United States
facility: San Diego Arthritis Medical Clinic
state: California
city: Aurora
country: United States
facility: Summit Clinical Research
state: Colorado
city: Boulder
country: United States
facility: Boulder Medical Center
state: Colorado
city: Englewood
country: United States
facility: Colorado Orthopedic Consultants
state: Colorado
city: Cos Cob
country: United States
facility: Plancher Orthopaedic and Sports Medicine
state: Connecticut
city: Miami
country: United States
facility: Community Research Foundation
state: Florida
city: Tampa
country: United States
facility: Tampa Medical Clinic
state: Florida
city: Cumming
country: United States
facility: Resurgens Orthopedics
state: Georgia
city: Boise
country: United States
facility: Intermountain Research Center
state: Idaho
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Morton Grove
country: United States
facility: Illinois Bone & Joint Institute
state: Illinois
city: Evansville
country: United States
facility: Wellborn Clinic
state: Indiana
city: Louisville
country: United States
facility: David Neustadt PSC
state: Kentucky
city: Wheaton
country: United States
facility: Center for Rheumatology and Bone Research
state: Maryland
city: Bay City
country: United States
facility: Great Lakes Research Group
state: Michigan
city: Missoula
country: United States
facility: Western Montana Clinic
state: Montana
city: Lincoln
country: United States
facility: Physician Research Collaboration
state: Nebraska
city: Reno
country: United States
facility: Arthritis Center of Reno
state: Nevada
city: Voorhees
country: United States
facility: Arthritis, Rheumatic & Back Disease Associates
state: New Jersey
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Johnstown
country: United States
facility: Brian Gunnlaugson, MD
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Arthritis Group
state: Pennsylvania
city: West Reading
country: United States
facility: Clinical Research Center of Reading
state: Pennsylvania
city: Germantown
country: United States
facility: SCRI
state: Tennessee
city: Harlingen
country: United States
facility: Valley Orthopedic Clinic
state: Texas
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Prometrika, LLC
name: Stephen Schmitz, MD
role: STUDY_DIRECTOR
References: