N/A
N=369
Safety and Effectiveness of Monovisc® Injection for Osteoarthritis of the Knee
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT00653432 ↗Enrolled (actual)
369
Serious AEs
3.8%
Results posted
Sep 2020
Primary outcome: 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 — 62.57; 56.14 Percentage of subjects — p=0.1450
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Monovisc® (Device); Saline (Other)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Anika Therapeutics, Inc.
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
62.57; 56.14 | 0.1450 |
| SECONDARY Evaluator Global Assessment Change From Baseline Through Week 12 (ITT) |
-28.6; -26.4; 59.1; 58.9; 30.4; 32.1 | 0.5824 |
| SECONDARY Patient Global Assessment Change From Baseline Through Week 12 (ITT) |
-28.8; -28.9; 62.9; 61.6; 33.7; 33.2 | 0.9136 |
| SECONDARY Range of Motion Change From Baseline Through Week 12 (ITT) |
1.5; 4.6; 116.3; 114.5; 117.8; 119.3 | 0.1699 |
| SECONDARY WOMAC Physical Function Score Change From Baseline Through Week 12 (ITT) |
-24.1; -22.3; 55.8; 54.1; 31.6; 31.7 | 0.3238 |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT00653432). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.