Anterior Cruciate Ligament Reconstruction Using Single Bundle and Double Bundle Techniques
Launched by VITA CARE · May 23, 2011
Trial Information
Current as of April 27, 2025
Unknown status
Keywords
ClinConnect Summary
The aim of this study is to compare the ACL reconstruction with only one bundle (one tunnel in the tibia and femur) with the procedure to reconstruct the the ACL with two bundles with 2 tunnels in the tibia and 2 in the femur (considered closest to the normal anatomy of of the ACL), both in terms of objective and subjective results.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Male or female.
- • 2. Body mass index (BMI), which corresponds to the ratio between weight in kilograms (pounds) and height in m2 (square meters) between 18.5 and 24.99.
- • 3. Anterior instability alone or associated with chondral lesions of up to 1cm or associated with meniscal injuries that do not alter the postoperative rehabilitation.
- • 4. Magnetic resonance imaging (MRI) confirming the ACL injury.
- • 5. Aged between 20 and 45 years.
- • 6. Not having asymmetric varus alignment, greater than or equal to 5 degrees (to eliminate cases with indication for osteotomy of the tibia), using panoramic radiographic comparison of the lower limbs in standing position.
- • 7. Absence of associated ligament instabilities (medial, lateral or posterior).
- • 8. No previous surgery on the affected knee.
- Exclusion Criteria:
- • 1. New post-surgical trauma after 12 months.
- • 2. Interruption of treatment / follow-up.
- • 3. Postoperative infection.
About Vita Care
Vita Care is a pioneering clinical trial sponsor dedicated to advancing healthcare through innovative research and development. With a strong focus on enhancing patient outcomes, Vita Care collaborates with leading medical institutions and researchers to conduct rigorous clinical trials across various therapeutic areas. Committed to ethical standards and patient safety, the organization leverages cutting-edge technologies and methodologies to streamline trial processes and ensure the integrity of data. By fostering partnerships and promoting transparency, Vita Care aims to accelerate the delivery of groundbreaking treatments to the market, ultimately improving the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
São Paulo, , Brazil
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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