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NCT03485157 · ClinicalTrials.gov registry record · Phase 2
Micronized dHACM vs. Saline in the Treatment of Osteoarthritis of the Knee
A Phase 2 study of Knee Osteoarthritis, sponsored by MiMedx Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 447
- Enrollment target
- 17
- Study locations
NCT03485157: Completed Phase 2 study of Knee Osteoarthritis, sponsored by MiMedx Group.
NCT03485157 is a Phase 2 study of Knee Osteoarthritis that has completed, run by MiMedx Group. The registered enrollment target is 447 participants, above the 300-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (49% higher). The trial reports 17 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03485157, a Phase 2 study of Knee Osteoarthritis, has completed, sponsored by MiMedx Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 447 participants
- Enrollment target
- 17
- Study locations
Study Summary
The purpose of this study is to determine the safety and effectiveness of micronized dehydrated human amnion chorion membrane as compared to the 0.9% Sodium Chloride Injection, USP placebo control for the treatment of knee osteoarthritis
Primary Outcome
Visual Analog Scale (VAS): 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain
Conditions Studied
Interventions
- DRUG Saline
- BIOLOGICAL Micronized dHACM
Study Locations (17)
Connecticut
- UConn Health - Farmington
- Bone & Joint Inst. at Hartford Hospital - Hartford
North Carolina
- Wake Reseach - Durham
- Wake Research - Raleigh
Pennsylvania
- University Orthopedics Center - Altoona
- University Orthopedics Center - State College
Alabama
- Central Research Associates, Inc - Birmingham
Arizona
- Fiel Family and Sports Medicine - Tempe
California
- Horizon Clinical Research - La Mesa
Florida
- Gulfcoast Research Institute - Sarasota
Georgia
- Paragon Sports Medicine - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 447 participants |
| Start Date | 2018-03-27 |
| Est. Completion | 2022-04-19 |
| Phase | Phase 2 |
What the finished NCT03485157 record still lists
NCT03485157 is an interventional study that assigns participants to a tested intervention. The registered 447 participants enrollment target is mid-sized for trials with a published cap, above the 300-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (49% higher).
The record links to 1 condition, with Knee Osteoarthritis appearing as the primary indexed condition, and to 2 interventions - of which Saline is the first listed.
NCT03485157 lists 17 locations in 14 states (Connecticut, North Carolina, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT03485157 about?
NCT03485157 is a clinical study titled "Micronized dHACM vs. Saline in the Treatment of Osteoarthritis of the Knee". The purpose of this study is to determine the safety and effectiveness of micronized dehydrated human amnion chorion membrane as compared to the 0.9% Sodium Chloride Injection, USP placebo control for the treatment of knee osteoarthritis
What is the current status of trial NCT03485157?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 447 participants. The study started on 2018-03-27. Estimated completion is 2022-04-19.
What conditions does trial NCT03485157 study?
This clinical trial studies the following conditions: Knee Osteoarthritis.
What interventions are being tested in trial NCT03485157?
The interventions under investigation include: Saline (DRUG), Micronized dHACM (BIOLOGICAL).
Who is sponsoring clinical trial NCT03485157?
This trial is sponsored by MiMedx Group, which has 32 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03485157 being conducted?
This trial has 17 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Knee Osteoarthritis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03485157's enrollment target sits among peer trials
447 10th of 101 higher than 92 of 101 other Knee Osteoarthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Knee Osteoarthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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