Tunnel Widening in Augmented ACL Integration Via PrP Enriched Collected Autologous Bone vs Standard ACL Technique

Launched by SCHULTHESS KLINIK · Jul 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two different surgical methods for fixing a torn anterior cruciate ligament (ACL), which is a common knee injury. The main goal is to see if using a special mixture of bone and platelet-rich plasma (a part of your blood that helps healing) in the knee during surgery leads to less widening of the tibial tunnel compared to the standard method that doesn’t use this mixture. Participants will be randomly assigned to one of the two groups, and they won’t know which group they are in. After 12 and 24 months, they will undergo medical exams and tests to check how well their knee is functioning.

To be eligible for the trial, participants need to be between 18 and 50 years old and have a primary ACL tear that occurred within the last 4 weeks to 6 months. They should not have other significant knee injuries or conditions, like osteoarthritis. Throughout the study, participants will be asked to report on their knee health and function at different times, including before surgery and at 6, 12, and 24 months after. This trial is currently recruiting participants, and it’s important for anyone considering joining to understand that they will be closely monitored and will contribute valuable information to help improve ACL repair techniques in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18-50 years
• • Primary ACL rupture
• • Time from injury to surgery: 4 weeks to 6 months
• • Single ACL rupture (isolated rupture)
• • ACL surgery with one of the participating senior surgeons
• • Informed Consent as documented by signature
• Exclusion Criteria:
• • Concomitant ligamentous instability/rupture
• • Requirement for Meniscus suture (partial resection accepted, hoop and roots remain intact)
• • Requirement for cartilage invasive treatment (debridement accepted)
• • Osteoarthritis at index knee joint
• • Leg axis deviation over 3° valgus or 4° varus
• • Claustrophobia (contra-indication for the MRI)
• • Women who are pregnant or breast feeding or intention to become pregnant during the study
• • Known or suspected non-compliance, drug or alcohol abuse
• • Inability of the patient to follow the study procedures, e.g. language problems, psychological disorders, dementia, etc.