Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04572256 · ClinicalTrials.gov registry record · Early Phase 1
MOntelukast as a Potential CHondroprotective Treatment Following Anterior Cruciate Ligament Reconstruction (MOCHA Trial)
A Early Phase 1 study of ACL Injury and Post-traumatic Osteoarthritis, sponsored by Austin V Stone.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04572256: Recruiting Early Phase 1 study of ACL Injury and Post-traumatic Osteoarthritis, sponsored by Austin V Stone.
NCT04572256 is a Early Phase 1 study of ACL Injury and Post-traumatic Osteoarthritis that is actively recruiting participants, run by Austin V Stone. The registered enrollment target is 30 participants, below the 502-participant average among 12 other ACL Injury trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04572256, a Early Phase 1 study of ACL Injury and Post-traumatic Osteoarthritis, is actively recruiting participants, sponsored by Austin V Stone.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a multicenter randomized, placebo-controlled trial to assess whether a 6-month course of oral montelukast after ACL reconstruction reduces systemic markers of inflammation and biochemical and imaging biomarkers of cartilage degradation. This study will specifically target older ACL reconstruction patients with concomitant meniscal injuries as this group is at greatest risk of rapid PTOA progression. Patients will randomly be assigned to receive oral montelukast (10 mg) versus placebo daily for 6 months after surgery.
Primary Outcome
Prostaglandin E2 is a potential inflammatory mediator, and it is being measured to directly assess whether treatment reduces this systemic inflammatory marker. Greater serum prostaglandin is associated with greater inflammation.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Montelukast
Study Locations (1)
Kentucky
- UK Healthcare at Turfland - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-02-01 |
| Est. Completion | 2027-06 |
| Phase | Early Phase 1 |
What NCT04572256 shows while recruiting
NCT04572256 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 502-participant average among 12 other ACL Injury trials with a reported enrollment target (94% lower).
The record links to 3 conditions, with ACL Injury appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04572256 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT04572256 about?
NCT04572256 is a clinical study titled "MOntelukast as a Potential CHondroprotective Treatment Following Anterior Cruciate Ligament Reconstruction (MOCHA Trial)". This is a multicenter randomized, placebo-controlled trial to assess whether a 6-month course of oral montelukast after ACL reconstruction reduces systemic markers of inflammation and biochemical and imaging biomarkers of cartilage degradation. This study will specifically target older ACL reconstru...
What is the current status of trial NCT04572256?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2021-02-01. Estimated completion is 2027-06.
What conditions does trial NCT04572256 study?
This clinical trial studies the following conditions: ACL Injury, Post-traumatic Osteoarthritis, Meniscus Tear.
What interventions are being tested in trial NCT04572256?
The interventions under investigation include: Placebo (DRUG), Montelukast (DRUG).
Who is sponsoring clinical trial NCT04572256?
This trial is sponsored by Austin V Stone, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04572256 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for ACL Injury
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 NCT04572256's enrollment target sits among peer trials
30 10th of 12 higher than 2 of 12 other ACL Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other ACL Injury 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
-
Michigan Split-belt Treadmill Training Program to Improve Long-Term Knee Biomechanics After ACL Reconstruction
RECRUITING · NA
-
Muscle O2 Saturation and Hemoglobin Levels During Rehabilitation From Arthroscopic Surgery
RECRUITING · NA
-
Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction
RECRUITING · Phase 4
-
Michigan Split-belt Treadmill Training Program to Improve Acute Knee Biomechanics After ACL Reconstruction
RECRUITING · NA
-
Baseline ACL Injury Risk Screening and Normative Data
RECRUITING
-
Mindfulness and ACL Surgery
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
- NCT00977977 · 30 participants · Phase 2
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
- NCT01459107 · 30 participants · Phase 2
Human Upper Extremity Allotransplantation
- NCT01666080 · 30 participants · NA
Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)
- NCT01720836 · 30 participants · Phase 1
Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
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