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1 mL NyDYN Injection for Osteoarthritis
Phase 2
Waitlist Available
Research Sponsored by Illinois Center for Orthopaedic Research and Education
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 1 year
Awards & highlights
Study Summary
This study is evaluating whether a single injection of amniotic membrane may help treat knee osteoarthritis.
Eligible Conditions
- Osteoarthritis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires
Secondary outcome measures
Exploratory Endpoint using Validated patient-reported outcome tools questionnaires
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: 1 mL NyDYN InjectionActive Control1 Intervention
30 patients (out of 90) will be blind to and randomly assigned to a 1 mL NyDYN injection.
Group II: 2 mL NuDYN InjectionActive Control1 Intervention
30 patients (out of 90) will be blind to and randomly assigned to a 2 mL NyDYN injection.
Group III: Placebo of Sterile SalinePlacebo Group1 Intervention
30 patients (out of 90) will be blind to and randomly assigned to a 2 mL dose of sterile saline.
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Who is running the clinical trial?
Illinois Center for Orthopaedic Research and EducationLead Sponsor
1 Previous Clinical Trials
1 Trials studying Osteoarthritis
Nikil ChariStudy ChairResearch Assistant
Jacob BarnhartStudy ChairResearch Assistant
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