Comparing two methods for fixing knee ligament grafts

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the outcomes of two different fixation methods for bone-patellar tendon-bone autografts used in anterior cruciate ligament (ACL) reconstruction. Patients will be randomly assigned to receive either the Endobutton CL BTB Fixation System or metal interference screws for femoral fixation. The study will assess various outcomes, including patient-reported results, knee laxity, range of motion, and muscle strength, with a primary focus on knee-related quality of life two years post-surgery. This is the first randomized controlled trial to directly compare these two fixation techniques.

Why it matters

Who can join: the full rules

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)

Where it's running

• Department of Orthopedic Surgery, St Olavs Hospital
  Trondheim, Norway Recruiting
• Rosenborgklinikken
  Trondheim, Norway Recruiting

Study contacts

• Principal investigator: Jon Olav Drogset, md phd — St. Olavs Hospital
• Study coordinator: Trond Olav Lundemo, md
• Email: TrondOlav.Lundemo@helse-nordtrondelag.no

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.