ACL Reconstruction With Shark Screw® or Biocomposite-interference Screws
Launched by BEZIRKSKRANKENHAUS SCHWAZ · Apr 3, 2024
Trial Information
Current as of July 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at two different types of screws used in surgery to repair a torn anterior cruciate ligament (ACL) in the knee. The main goal is to find out if a special human bone screw can help reduce the widening of the tunnel created during surgery compared to a standard biocomposite screw. Researchers will also check how often the ACL tears again after surgery and will assess knee function through questionnaires before and after the operation. Participants will undergo MRI scans and CT scans at various points to monitor their recovery.
To be eligible for this study, participants must be between 65 and 74 years old and have a confirmed ACL tear that requires surgery. They should have had their injury within the last six months and have a healthy opposite knee. However, individuals with a history of previous ACL tears on the same knee, certain bone or inflammatory diseases, or unstable knee conditions will not be included. If you decide to participate, you'll be closely monitored for up to two years after your surgery to understand how well the different screws work in helping you recover.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • MRI-verified rupture of the anterior cruciate ligament
- • Indication for replacement surgery
- • Surgery within 6 months of injury
- • Uninjured contralateral knee
- Exclusion Criteria:
- • Previous rupture of the anterior cruciate ligament on the side to be operated on (rerupture)
- • Primary bone disease
- • inflammatory disease
- • Unstable meniscus
- • complete rupture of a collateral ligament
- • early rerupture during the examination period (early rerupture)
About Bezirkskrankenhaus Schwaz
Bezirkskrankenhaus Schwaz is a leading healthcare institution located in Austria, dedicated to providing high-quality medical care and advancing clinical research. As a prominent clinical trial sponsor, it focuses on innovative therapeutic approaches and patient-centered studies, collaborating with multidisciplinary teams to enhance treatment outcomes. The hospital is committed to ethical standards and regulatory compliance, ensuring the safety and well-being of participants while contributing to the advancement of medical knowledge. Through its robust research initiatives, Bezirkskrankenhaus Schwaz plays a vital role in the development of new therapies, ultimately aiming to improve patient care and health outcomes in the community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Schwaz, Tirol, Austria
Schwaz, Tirol, Austria
Patients applied
Trial Officials
Alexander Rofner-Moretti, MD
Principal Investigator
Bezirkskrankenhaus Schwaz Betriebsgesellschaft m.b.H
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported