Double Bundle Anterior Cruciate Ligament Reconstruction

Summary

There has been an increased awareness towards ACL (anterior cruciate ligament) injuries for Norwegian teams, particularly in handball and soccer. The reported number of reconstructions in Norway ranges from 1500 to 2000 per year, and in the United States from 50,000 to 100,000 per year, making ACL reconstruction one of the most common orthopaedic procedures performed, especially among young, active and healthy individuals. However, reports state that there is a subset of patients (10-40%) who remain subjectively and objectively unstable and/or are unable to regain prior function. Additionally, it has been reported that degenerative joint disease is associated with traditional single-bundle ACL reconstructions in up to 50% of the patients in long term follow up studies.

It is well known that the ACL is composed of 2 functional bundles named after their tibial attachments, the anteromedial (AM) and posterolateral (PL) bundles.

It is believed that the current single-graft, single-bundle technique for reconstructing the anterior cruciate ligament does not anatomically reconstruct either one of these bundles.

In the last two years, the double bundle technique has been introduced and a few clinical studies are available, however only a few RCTs.

Further study is very important to determine if double-bundle ACL reconstructions should be performed, if single-bundle reconstructions can be adjusted to better adapt to their biomechanical insufficiency in restoring internal rotation torques and valgus moments, and also in trying to identify which patients might better benefit from single-bundle versus double-bundle ACL reconstructions.

Conditions

• Knee Outcome, Subjective

Interventions

PROCEDURE

Single bundle

Procedure: Transarthroscopic technique with medial portal placement of the femoral tunnel. Harvest of the semitendinosus/gracilis (ST/G) tendons through a 3-5 cm incision at the pes anserinus. The femoral tunnel is positioned at the anatomic foot print determined by the anatomic landmarks. The graft will be fixed with an Endobutton CL on the femur and with an Biosure PK screw in the tibia with the knee close to extension. Prior to the final fixation, the knee will be taken through flexion and extension movements.The surgery will be carried out by an experienced knee surgeon.

PROCEDURE

Double bundle

Procedure: Transarthroscopic technique. Harvest of the semitendinosus/gracilis (ST/G) tendons through a 3-5 cm incision at the pes anserinus.Through a medial portal 2 tunnels will be anatomically placed in the foot print on the femur and the two tibial tunnels will be placed using the Smith \& Nephew drill guide. The graft will be fixed with 2 Endobuttons on the femur and with 2 Biosure PK screws in the tibia. Prior to the final fixation, the knee will be taken through 20 flexion and extension movements. The PL bundle will be fixed with the knee close to ful extension. The surgery will be carried out by an experienced knee surgeon.

Sponsors & Collaborators

• Oslo University Hospital

  lead OTHER

Principal Investigators

• Lars Engebretsen, Phd, MD · Supervisor

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-01-31

Primary Completion

2017-06-20

Completion

2017-06-20

Countries

• Norway

Study Locations