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Search / Trial NCT02918734

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

Anterior Cruciate Ligament Bone Patellar Tendon Bone Grafting

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.

Locations

Trondheim, , Norway

Trondheim, , Norway

Patients applied

0 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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