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Protocol for the Clinical Evaluation of Lyophilized Amniotic Fluid in the Treatment of Knee Osteoarthritis
N/A
Waitlist Available
Research Sponsored by MiMedx Group, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4weeks, 6weeks, 3 months, 16 weeks, 6 months
Summary
To evaluate the efficacy of Lyophilized amniotic fluid as compared to the Saline Injection, placebo control in the treatment of moderate osteoarthritis of the knee.
Eligible Conditions
- Osteoarthritis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4weeks, 6weeks, 3 months, 16 weeks, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4weeks, 6weeks, 3 months, 16 weeks, 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Reduction in Pain
Secondary study objectives
Activity of Daily Living Questionnaire
Knee Injury and Osteoarthritis Outcome Score
Range of Motion
+1 moreTrial Design
3Treatment groups
Active Control
Placebo Group
Group I: 4mL amniotic fluidActive Control1 Intervention
Amniotic Fluid: 4mL dose of amniotic fluid
Group II: 4mL2x amniotic fluidActive Control1 Intervention
Amniotic Fluid: 4mL 2x dose of amniotic fluid
Group III: 4mL Saline PlaceboPlacebo Group1 Intervention
Normal Saline
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Who is running the clinical trial?
MiMedx Group, Inc.Lead Sponsor
35 Previous Clinical Trials
2,673 Total Patients Enrolled
3 Trials studying Osteoarthritis
550 Patients Enrolled for Osteoarthritis
David Mason, MDStudy DirectorChief Medical Officer
4 Previous Clinical Trials
143 Total Patients Enrolled