Fertilized ACL for Anterior Cruciate Ligament Injury
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how ACL reconstruction surgery using bone marrow aspirate, DBM (a bone graft material), and an internal brace affects athletes' ability to return to play. It compares outcomes and biomechanics between those who undergo the surgery and those who do not. The trial seeks athletes aged 14-26 with ACL injuries who desire surgery to improve knee stability. Researchers will monitor participants for two years to assess recovery and performance.
As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in ACL injury recovery.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this ACL reconstruction technique is safe for patients?
Research has shown that using a surgical safety checklist significantly reduces the risk of problems during surgery. One study found that complications decreased from 15.4% to 10.6% with the checklist. This indicates that fewer issues occur when specific safety steps are followed.
Another study discovered that surgical patients had better outcomes, with a 20% higher survival rate than expected based on the severity of their conditions. This suggests that surgeries are generally becoming safer.
Although surgery can still pose risks, these findings demonstrate that following safety protocols greatly improves patient safety.12345Why are researchers excited about this trial?
Researchers are excited about the approach using bone marrow aspirate, demineralized bone matrix (DBM), and an internal brace for ACL reconstruction because it combines regenerative medicine with structural support. Unlike traditional ACL surgeries that rely solely on grafts, this method incorporates bone marrow aspirate, which is rich in stem cells, to potentially enhance healing and tissue regeneration. The internal brace provides immediate stability, allowing for a potentially quicker return to physical activity. By integrating these innovative elements, the treatment aims to improve recovery times and long-term outcomes compared to standard reconstruction techniques.
What evidence suggests that ACL reconstruction is effective for return to play?
This trial will compare outcomes for patients undergoing ACL reconstruction surgery with those who do not receive the surgery. Research has shown that ACL reconstruction surgery usually helps people return to sports activities. Studies have found that patients often feel better, move more easily, and experience less pain after the surgery. Many notice significant improvements in their ability to perform physical activities once they have recovered. This surgery has successfully helped many athletes return to their previous level of sport. While results can vary, the overall evidence supports that ACL reconstruction is effective in helping people play sports again.678910
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative Assessment
Participants provide baseline characteristics and undergo pre-operative physical exams
Surgery and Initial Recovery
Participants undergo ACL reconstruction surgery and initial recovery
Rehabilitation and Monitoring
Participants undergo rehabilitation and are monitored for return to play readiness
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Fertilized ACL
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
These patients receive the surgery and are followed for two years for outcomes.
These patients do not need and don't receive surgery and are followed for two years to compare to the surgery treatment group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Marshall University
Lead Sponsor
Arthrex, Inc.
Industry Sponsor
Citations
Patient-Reported Outcomes: Understanding Surgical Efficacy ...
Generic and disease-specific patient-reported outcome measures capture health-related quality of life, functional status, and pain.
Impact of surgical care pathways on efficiency and outcomes ...
Several studies have confirmed the positive impact of CPs in orthopedic surgery. For example, the implementation of CP in hip replacement ...
Consensus recommendations on how to assess the quality ...
We provide a framework for surgical outcome assessment and quality improvement after medical interventions, that integrates the main stakeholders' perspectives.
Effect of surgeon‐specific feedback on surgical outcomes: ...
This systematic review supports the use of surgeon-level feedback to improve outcomes. The strength of this finding is limited by reliance on before and after ...
Publication of surgeon specific outcome data: A review ...
Government-mandated publication of named surgeon-specific outcome data (SSD) has recently been introduced across nine surgical speciality areas in England.
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aha.org
aha.org/press-releases/2025-08-04-new-data-show-better-outcomes-hospitalized-surgical-patientsNew Data Show Better Outcomes for Hospitalized Surgical ...
In the first quarter of 2024, hospitalized surgical patients were nearly 20% more likely to survive than expected — based on the severity of ...
Enhancing Surgical Outcomes: Evaluating the Impact of ...
Research has shown that following the surgical safety checklist provided by the World Health Organization (WHO) can significantly reduce these complications.
Effect of a Comprehensive Surgical Safety System on ...
The proportion of patients with one or more complications decreased from 15.4% to 10.6% (P<0.001). In-hospital mortality decreased from 1.5% (95 ...
Patient safety
Some estimates suggest that as many as 4 in 10 patients are harmed in primary and ambulatory settings, while up to 80% (23.6–85%) of this harm ...
ACS National Surgical Quality Improvement Program
In a study comparing ACS NSQIP data to claims data, ACS NSQIP identified 61% more complications, including 97% more surgical site infections. Risk-adjusted. Why ...
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