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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00653432
• Other study ID #: Monovisc-0702
• Status: Completed
• Phase: N/A
• Start date: January 2008
• Est. completion date: February 2010

Study information

• Verified date: June 2023
• Source: Anika Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 information / eligibility

• Status: Completed
• Enrollment: 369
• Est. completion date: February 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Monovisc®
Intra-articular injection

Other:
• Saline
0.9% Sterile Saline

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
United States	Summit Clinical Research	Aurora	Colorado
United States	Great Lakes Research Group	Bay City	Michigan
United States	Intermountain Research Center	Boise	Idaho
United States	Boulder Medical Center	Boulder	Colorado
United States	Providence Clinical Research	Burbank	California
United States	Rush University Medical Center	Chicago	Illinois
United States	Plancher Orthopaedic and Sports Medicine	Cos Cob	Connecticut
United States	Resurgens Orthopedics	Cumming	Georgia
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Colorado Orthopedic Consultants	Englewood	Colorado
United States	Wellborn Clinic	Evansville	Indiana
United States	SCRI	Germantown	Tennessee
United States	Valley Orthopedic Clinic	Harlingen	Texas
United States	Clinical Research Consultants	Hoover	Alabama
United States	Brian Gunnlaugson, MD	Johnstown	Pennsylvania
United States	Physician Research Collaboration	Lincoln	Nebraska
United States	David Neustadt PSC	Louisville	Kentucky
United States	Novara Clinical Research	Mesa	Arizona
United States	Community Research Foundation	Miami	Florida
United States	Western Montana Clinic	Missoula	Montana
United States	Illinois Bone & Joint Institute	Morton Grove	Illinois
United States	The Arthritis Group	Philadelphia	Pennsylvania
United States	Arizona Research Center	Phoenix	Arizona
United States	Arthritis Center of Reno	Reno	Nevada
United States	San Diego Arthritis Medical Clinic	San Diego	California
United States	Tampa Medical Clinic	Tampa	Florida
United States	Tuscon Orthopaedic Institute	Tucson	Arizona
United States	Arthritis, Rheumatic & Back Disease Associates	Voorhees	New Jersey
United States	Clinical Research Center of Reading	West Reading	Pennsylvania
United States	Center for Rheumatology and Bone Research	Wheaton	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Anika Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	12 Weeks
Secondary	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.	12 Weeks
Secondary	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.	12 Weeks
Secondary	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.	12 Weeks