Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04636229 · ClinicalTrials.gov registry record · Phase 3
Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee
A Phase 3 study of Knee Osteoarthritis, sponsored by Organogenesis.
- Completed
- Registry status
- Phase 3
- Development phase
- 516
- Enrollment target
- 20
- Study locations
NCT04636229: Completed Phase 3 study of Knee Osteoarthritis, sponsored by Organogenesis.
NCT04636229 is a Phase 3 study of Knee Osteoarthritis that has completed, run by Organogenesis. The registered enrollment target is 516 participants, above the 299-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (73% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04636229, a Phase 3 study of Knee Osteoarthritis, has completed, sponsored by Organogenesis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 516 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is being conducted to evaluate the efficacy and safety of ASA compared to placebo in the management of osteoarthritis (OA) symptoms of the knee.
Primary Outcome
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL Amniotic Suspension Allograft
Study Locations (20)
California
- Tri West Research Associates - El Cajon
- Horizon Clinical Research Center - La Mesa
- Actca, A Member of the Allliance Inc. - Los Angeles
- University of California at Los Angeles - Los Angeles
- Stanford Medicine - Redwood City
- University of California at Davis - Sacramento
Alabama
- Central Research Associates - Birmingham
- Alabama Clinical Therapeutics - Birmingham
- AMR Mobile - Mobile
Arizona
- Arizona Arthritis & Rheumatology Research - Glendale
- Fiel Family & Sports Medicine/ CCT Research - Tempe
- Arizona Arthritis & Rheumatology Research - Tucson
Illinois
- Chicago Clinical Research Institute Inc - Chicago
- Rush University Medical Center - Chicago
- Affinity Health - Oak Brook
Florida
- AARDS Research, Inc. - Aventura
- Gulfcoast Research Institute - Sarasota
Georgia
- Pinnacle Trials, Inc. - Stockbridge
Idaho
- Injury Care Research - Boise
Maryland
- Sinai Hospital of Baltimore - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 516 participants |
| Start Date | 2020-12-14 |
| Est. Completion | 2025-08-19 |
| Phase | Phase 3 |
What the finished NCT04636229 record still lists
NCT04636229 is an interventional study that assigns participants to a tested intervention. The registered 516 participants enrollment target is mid-sized for trials with a published cap, above the 299-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (73% higher).
The record links to 1 condition, with Knee Osteoarthritis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04636229 names 20 study sites across 8 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT04636229 about?
NCT04636229 is a clinical study titled "Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee". This study is being conducted to evaluate the efficacy and safety of ASA compared to placebo in the management of osteoarthritis (OA) symptoms of the knee.
What is the current status of trial NCT04636229?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 516 participants. The study started on 2020-12-14. Estimated completion is 2025-08-19.
What conditions does trial NCT04636229 study?
This clinical trial studies the following conditions: Knee Osteoarthritis.
What interventions are being tested in trial NCT04636229?
The interventions under investigation include: Placebo (DRUG), Amniotic Suspension Allograft (BIOLOGICAL).
Who is sponsoring clinical trial NCT04636229?
This trial is sponsored by Organogenesis, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04636229 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. 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 NCT04636229's enrollment target sits among peer trials
516 7th of 101 higher than 95 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Dronabinol After Arthroscopic Surgery
RECRUITING · Phase 3
-
Microfragmented Adipose Tissue Compared to Saline Injection for the Treatment of Knee Osteoarthritis
ACTIVE NOT RECRUITING · Phase 3
-
Phase 3 Adductor Canal Block With EXPAREL in Subjects Undergoing Primary Unilateral Total Knee Arthroplasty
COMPLETED · Phase 3
-
Microfragmented Adipose Tissue Compared to Corticosteroid Injection for the Treatment of Knee Osteoarthritis
COMPLETED · Phase 3
-
Patient-Reported Outcomes in Evaluating Lorecivivint (SM04690) for Moderate to Severe Knee Osteoarthritis (STRIDES-1)
COMPLETED · Phase 3
-
Evaluating Changes in Synovial Fluid Before and After GAE for Knee Osteoarthritis
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05933083 · 516 participants · NA
MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation
- NCT05676450 · 517 participants · NA
Feasibility and Clinical Utility of Cell-free DNA (cfDNA) in Identifying Actionable Alterations and Minimal Residual Disease for Lymphoma Patients Across Community Centers in Texas
- NCT05577819 · 515 participants · NA
Prevalence and Prediction of ATTR in Ambulatory Patients With HFpEF
- NCT06804837 · 515 participants · NA
Implement and Test Visual Consent Template and Process
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI