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Completed

NCT Number: NCT00653432

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

The purpose of this study is to determine whether intra-articular injection of Monovisc® hyaluronic acid provides symptomatic relief of osteoarthritis of the knee.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Monovisc®

Device

Intra-articular injection

Other names: Sodium Hyaluronate, Hyaluronic Acid Gel

Saline

Other

0.9% Sterile Saline

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

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Anika Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Apr 7, 2008
Registry last updated
Jul 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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