Fixation of Patellar Tendon Grafts in Anterior Cruciate Ligament Reconstruction. Endobutton vs Metal Interference Screws
Launched by ST. OLAVS HOSPITAL · Sep 27, 2016
Trial Information
Current as of July 25, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two different methods for fixing a bone-patellar tendon-bone (BPTB) graft during surgery for a torn anterior cruciate ligament (ACL). The researchers want to compare the traditional method using metal interference screws with a newer method called the Endobutton, which is designed to hold the graft in place. The goal is to see which method provides better results for patients undergoing ACL reconstruction, as there hasn’t been a direct comparison of these two techniques before.
To participate in this trial, individuals must be between the ages of 18 and 74 and have a primary ACL tear that requires surgery at least six weeks after the injury. Patients will need to sign a consent form agreeing to take part in the study. Those with certain knee issues or previous surgeries on the same knee may not be eligible. Participants can expect to be carefully monitored throughout the process, and their recovery will be followed to assess how well each fixation method works. This study is important because it could help improve surgical outcomes for patients with knee injuries.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Primary reconstruction of ACL ruptures
- • Surgery at least 6 weeks after injury
- • The patient must accept and sign the informed consent form before surgery
- Exclusion Criteria:
- • Medical indication for using another graft than BPTB autograft (such as history of anterior knee pain or occupations etc. requiring frequent kneeling)
- • Previous major surgical procedures in the same knee
- • Major additional injuries in the knee (posterior cruciate ligament, lateral collateral ligament, medial collateral ligament, sutured meniscus lesions and major cartilage lesions undergoing cartilage repair)
- • Contralateral ACL injury (treated or untreated)
- • Present or former serious illness that makes follow-up or rehabilitation difficult (e.g. alcohol or drug abuse, psychiatric disease)
About St. Olavs Hospital
St. Olavs Hospital is a leading healthcare institution located in Trondheim, Norway, renowned for its commitment to advancing medical research and improving patient care. As a key clinical trial sponsor, the hospital is dedicated to conducting innovative research across various therapeutic areas, fostering collaboration among multidisciplinary teams of healthcare professionals and researchers. With state-of-the-art facilities and a patient-centric approach, St. Olavs Hospital aims to enhance clinical outcomes and contribute to the global body of medical knowledge through rigorous and ethically conducted clinical trials.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Trondheim, , Norway
Trondheim, , Norway
Patients applied
Trial Officials
Jon Olav Drogset, md phd
Principal Investigator
St. Olavs Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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