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

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Monovisc®
Saline
Sponsored by
Anika Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Monovisc®, Hyaluronic Acid Gel, Injection, Knee

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Research Consultants
  • Novara Clinical Research
  • Arizona Research Center
  • Tuscon Orthopaedic Institute
  • Providence Clinical Research
  • San Diego Arthritis Medical Clinic
  • Summit Clinical Research
  • Boulder Medical Center
  • Colorado Orthopedic Consultants
  • Plancher Orthopaedic and Sports Medicine
  • Community Research Foundation
  • Tampa Medical Clinic
  • Resurgens Orthopedics
  • Intermountain Research Center
  • Rush University Medical Center
  • Illinois Bone & Joint Institute
  • Wellborn Clinic
  • David Neustadt PSC
  • Center for Rheumatology and Bone Research
  • Great Lakes Research Group
  • Western Montana Clinic
  • Physician Research Collaboration
  • Arthritis Center of Reno
  • Arthritis, Rheumatic & Back Disease Associates
  • Altoona Center for Clinical Research
  • Brian Gunnlaugson, MD
  • The Arthritis Group
  • Clinical Research Center of Reading
  • SCRI
  • Valley Orthopedic Clinic
  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Monovisc®

Saline

Arm Description

Injectable Hyaluronic Acid Gel

0.9% Sterile Saline

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
March 5, 2008
Last Updated
June 21, 2023
Sponsor
Anika Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00653432
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anika Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Monovisc®, Hyaluronic Acid Gel, Injection, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
369 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monovisc®
Arm Type
Experimental
Arm Description
Injectable Hyaluronic Acid Gel
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
0.9% Sterile Saline
Intervention Type
Device
Intervention Name(s)
Monovisc®
Other Intervention Name(s)
Sodium Hyaluronate, Hyaluronic Acid Gel
Intervention Description
Intra-articular injection
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
0.9% Sterile Saline
Primary Outcome Measure Information:
Title
Percentage of Subjects Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score (ITT) >=40% and 15 mm From Baseline Through 12 Weeks
Description
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.
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Evaluator Global Assessment Change From Baseline Through Week 12 (ITT)
Description
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.
Time Frame
12 Weeks
Title
Patient Global Assessment Change From Baseline Through Week 12 (ITT)
Description
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.
Time Frame
12 Weeks
Title
Range of Motion Change From Baseline Through Week 12 (ITT)
Description
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.
Time Frame
12 Weeks
Title
WOMAC Physical Function Score Change From Baseline Through Week 12 (ITT)
Description
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.
Time Frame
12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Schmitz, MD
Organizational Affiliation
Prometrika, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Consultants
City
Hoover
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Novara Clinical Research
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Tuscon Orthopaedic Institute
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Providence Clinical Research
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
San Diego Arthritis Medical Clinic
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Summit Clinical Research
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80013
Country
United States
Facility Name
Boulder Medical Center
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Colorado Orthopedic Consultants
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80110
Country
United States
Facility Name
Plancher Orthopaedic and Sports Medicine
City
Cos Cob
State/Province
Connecticut
ZIP/Postal Code
06807
Country
United States
Facility Name
Community Research Foundation
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Tampa Medical Clinic
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Resurgens Orthopedics
City
Cumming
State/Province
Georgia
ZIP/Postal Code
30041
Country
United States
Facility Name
Intermountain Research Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Illinois Bone & Joint Institute
City
Morton Grove
State/Province
Illinois
ZIP/Postal Code
60053
Country
United States
Facility Name
Wellborn Clinic
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
David Neustadt PSC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Center for Rheumatology and Bone Research
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Great Lakes Research Group
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Western Montana Clinic
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Physician Research Collaboration
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Arthritis Center of Reno
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Arthritis, Rheumatic & Back Disease Associates
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Brian Gunnlaugson, MD
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15901
Country
United States
Facility Name
The Arthritis Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
Country
United States
Facility Name
Clinical Research Center of Reading
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
SCRI
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Valley Orthopedic Clinic
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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