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Information about a piece of news titled Double-bundle vs single-bundle ACL reconstruction - new RCT

Double-bundle vs single-bundle ACL reconstruction - new RCT


A new large-scale RCT with more than 100 included subjects is ready for analyses. The primary outcome is the difference between the 2 treatments as mean change of the KOOS QoL subscore from baseline to the 2-years follow-up.

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Anterior cruciate ligament (ACL) reconstruction is one of the most common orthopaedic procedures performed among young, active and healthy individuals.

The double-bundle ACL reconstruction technique was developed to improve both the anatomical and biomechanical properties of the knee after the reconstruction, due to the restoration of both of the bundles of the ACL: the anteromedial (AM) and the posterolateral (PL) bundle.

Their different insertion sites and tension patterns during knee motion, were supposed to resemble the native ACL more closely than the traditional single-bundle reconstruction. Although many laboratory studies support these findings, clinical studies are less convincing. 

Large, high-quality studies, with focus on the patient´s subjective outcome has been requested in order to decide if double-bundle reconstruction technique should continue to be an option for the ACL injured patients. 

This study was designed to compare the double-bundle to the single-bundle ACL reconstruction with focus on patient reported outcome measurements.

Recruitment finished

The protocol was published at ClinicalTrials.gov December 15 2009 (Clinical trials ID: NCT01033188). The inclusion period started Jan 1 2010. The follow-up was performed at 12 and 24 months (1 and 2 years) after index surgery, and the study was completed with the 2-years follow-up of the last subject on June 17 2017.

Large joint venture project

The project leader is MD Cathrine Aga (picture) with Professor Lars Engebretsen as her main supervisor.

This project is a joint venture from Martina Hansens Hospital, Oslo Sports Trauma Research Center, Oslo University Hospital, Norwegian School of Sport Sciences, and Lovisenberg Diaconal Hospital. 

Co-supervisors/co-workers are Stig Heir, May Arna Risberg, Steinar Johansen, with statistical advise by Morten Wang Fagerland. 

Read more about the trial and the statistical analysis plan.