About this trial
In this randomized controlled trial the investigators will compare the results after primary anterior cruciate ligament (ACL) reconstruction using two different methods for femoral fixation of a bone-patellar tendon-bone (BPTB) autograft. Interference screws have been the standard method for fixing the femoral side of BPTB grafts; however, several pitfalls have been reported. Cortical fixation with the Endobutton CL BTB Fixation System has become available and the clinical results have been described as promising; however, no randomized controlled trials comparing these two femoral fixation methods have been conducted, and there is no published data that confirms that the bone block heals in the tunnel with the newer method.
The aim of our study is to compare the outcome after primary ACL reconstruction with BPTB autografts using the Endobutton CL BTB or metal interference screw for femoral fixation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Primary reconstruction of ACL ruptures
Surgery at least 6 weeks after injury
The patient must accept and sign the informed consent form before surgery
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Endobutton CL BTB
DeviceACL reconstruction with Endobutton CL BTB
Metal interference screw
DeviceACL reconstruction with metal interference screw
Treatment groups
Trial outcomes
Primary outcomes
Knee related quality of life
KOOS subscale "knee related Quality of life (QOL)"
Secondary outcomes
Tegner activity scale
Lachman test
Anterior translation of the tibia
Muscular strength
Biodex dynamometer
Bone block integration
CT scan
Other outcomes
Complications
Registration
Reoperations
Registration
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
St. Olavs Hospital
Lead sponsor
Rosenborgklinikken
Collaborator