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NCT06311513 · ClinicalTrials.gov registry record · Phase 4

Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction

A Phase 4 study of Anterior Cruciate Ligament Injuries and ACL Injury, sponsored by Hospital for Special Surgery, New York.

Recruiting
Registry status
Phase 4
Development phase
40
Enrollment target
2
Study locations

NCT06311513: Recruiting Phase 4 study of Anterior Cruciate Ligament Injuries and ACL Injury, sponsored by Hospital for Special Surgery, New York.

NCT06311513 is a Phase 4 study of Anterior Cruciate Ligament Injuries and ACL Injury that is actively recruiting participants, run by Hospital for Special Surgery, New York. The registered enrollment target is 40 participants, below the 321-participant average among 24 other Anterior Cruciate Ligament Injuries trials with a reported enrollment target (88% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06311513, a Phase 4 study of Anterior Cruciate Ligament Injuries and ACL Injury, is actively recruiting participants, sponsored by Hospital for Special Surgery, New York.

RECRUITING
Registry status
Phase 4
Development phase
40 participants
Enrollment target
2
Study locations

Study Summary

The goal of this pilot randomized clinical trial is to look into the efficacy of concentrated bone marrow aspirate (cBMA) in improving post traumatic osteoarthritis (PTOA) symptoms in patients undergoing revision anterior cruciate ligament reconstruction surgery. The main questions it aims to answer are whether clinical outcomes, such as pain, are improved in patients who get cBMA with surgery, if there is a change in circulating markers of inflammation and what part of the cellular and molecular composition of cBMA may explain its effects.

Primary Outcome

The primary outcome measured for this study will be postoperative knee pain. This will be achieved using the Knee Injury and Osteoarthritis Outcome Score (KOOS) standardized questionnaire, which will be electronically delivered to participants at baseline and at 6-weeks, 6-months, 12-months and 24-months postoperatively. This questionnaire measures 42 items in a Likert scale for 5 different dimensions: pain, other symptoms, activities of daily living, function in sports and recreation and knee-r

Conditions Studied

Anterior Cruciate Ligament Injuries ACL Injury Bone Marrow Aspirate Concentrate Post-Traumatic Osteoarthritis of Knee

Interventions

  • BIOLOGICAL Concentrated Bone Marrow Aspirate Injection
  • PROCEDURE Sham Incision
  • PROCEDURE Revision Anterior Cruciate Ligament Reconstruction

Study Locations (2)

Georgia

  • Emory Orthopaedics & Spine Center - Atlanta

New York

  • Hospital for Special Surgery - New York

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2024-01-22
Est. Completion 2028-12
Phase Phase 4
Hospital for Special Surgery, New York

194 total trials

What NCT06311513 shows while recruiting

NCT06311513 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 321-participant average among 24 other Anterior Cruciate Ligament Injuries trials with a reported enrollment target (88% lower).

The record links to 4 conditions, with Anterior Cruciate Ligament Injuries appearing as the primary indexed condition, and to 3 interventions - of which Concentrated Bone Marrow Aspirate Injection is the first listed.

NCT06311513 reports a single indexed study location in Georgia, New York.

Frequently Asked Questions

What is clinical trial NCT06311513 about?

NCT06311513 is a clinical study titled "Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction". The goal of this pilot randomized clinical trial is to look into the efficacy of concentrated bone marrow aspirate (cBMA) in improving post traumatic osteoarthritis (PTOA) symptoms in patients undergoing revision anterior cruciate ligament reconstruction surgery. The main questions it aims to answer...

What is the current status of trial NCT06311513?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2024-01-22. Estimated completion is 2028-12.

What conditions does trial NCT06311513 study?

This clinical trial studies the following conditions: Anterior Cruciate Ligament Injuries, ACL Injury, Bone Marrow Aspirate Concentrate, Post-Traumatic Osteoarthritis of Knee.

What interventions are being tested in trial NCT06311513?

The interventions under investigation include: Concentrated Bone Marrow Aspirate Injection (BIOLOGICAL), Sham Incision (PROCEDURE), Revision Anterior Cruciate Ligament Reconstruction (PROCEDURE).

Who is sponsoring clinical trial NCT06311513?

This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06311513 being conducted?

This trial has 2 study locations across Georgia, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Anterior Cruciate Ligament Injuries

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 NCT06311513's enrollment target sits among peer trials

40 21st of 24 higher than 3 of 24 other Anterior Cruciate Ligament Injuries trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Anterior Cruciate Ligament Injuries 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

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More recruiting context for NCT06311513

Source: ClinicalTrials.gov NCT06311513, the US trial registry maintained by the National Library of Medicine. NCT06311513 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.