Status:
COMPLETED
Safety and Effectiveness of Monovisc® Injection for Osteoarthritis of the Knee
Lead Sponsor:
Anika Therapeutics, Inc.
Conditions:
Osteoarthritis
Eligibility:
All Genders
35-75 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
369 Patients enrolled
Trial Details
Trial ID
NCT00653432
Start Date
January 1 2008
End Date
February 1 2010
Last Update
July 11 2023
Active Locations (31)
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1
Clinical Research Consultants
Hoover, Alabama, United States, 35216
2
Novara Clinical Research
Mesa, Arizona, United States, 85206
3
Arizona Research Center
Phoenix, Arizona, United States, 85023
4
Tuscon Orthopaedic Institute
Tucson, Arizona, United States, 85712