ACL Reconstruction With/Without Internal Bracing for Anterior Cruciate Ligament Injury
Trial Summary
Do I need to stop my current medications for the ACL reconstruction 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 data supports the effectiveness of ACL Reconstruction with or without internal bracing for anterior cruciate ligament injury?
Research shows that a well-structured rehabilitation program after ACL reconstruction, focusing on reducing pain and swelling, regaining motion and strength, and improving balance, can help patients recover effectively without stability issues. Additionally, surgical reconstruction of the ACL often leads to full recovery of function and sports activity in many cases.12345
Is ACL reconstruction with internal bracing safe for humans?
How does ACL reconstruction with internal bracing differ from other treatments for ACL injuries?
ACL reconstruction with internal bracing is unique because it uses a suture tape to protect the graft during healing, allowing for earlier and more aggressive rehabilitation compared to standard ACL reconstruction. This method aims to reduce the risk of rerupture and improve recovery outcomes by providing additional support to the reconstructed ligament.19101112
What is the purpose of this trial?
This trial is testing whether adding an internal brace during ACL surgery helps patients recover faster and have better outcomes. It focuses on young adults and athletes who need strong and stable knees. The brace is supposed to make the new ligament stronger and more stable while it heals. Internal bracing of the anterior cruciate ligament (ACL) reinforces the ligament and encourages natural healing by protecting it during the healing phase and supporting early mobilization.
Research Team
David Trofa, MD
Principal Investigator
Assistant Professor of Orthopedic Surgery
Eligibility Criteria
This trial is for patients treated by Columbia University Sports Medicine Service, aged 12 or older, with a first-time ACL injury confirmed by clinical exam and MRI. It's not suitable for those with previous knee surgery, other knee injuries, neuromuscular disorders affecting the leg, anesthesia risks, or who can't/won't follow the study plan.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Participants undergo ACL reconstruction with or without internal brace augmentation
Initial Recovery
Participants begin initial recovery and rehabilitation post-surgery
Rehabilitation
Participants continue rehabilitation to regain knee function and strength
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ACL Reconstruction
- Standardized Rehabilitation Protocol
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor