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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 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.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03485157
The ClinicalTrials.gov registry entry for NCT03485157 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 447 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 300-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (49% higher). The listed sponsor is MiMedx Group, which has 32 total studies on file at ClinicalTrials.gov.
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 reports 17 study locations spanning 14 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.