Double Bundle Anterior Cruciate Ligament Reconstruction
Condition: Knee Outcome, Subjective
Study type: Interventional

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.
    

Detailed description: 
      The aim of this study:

      The primary aim is to compare the two operational techniques: single bundle hamstrings versus
      double bundle hamstrings ACL reconstruction, using the KOOS (Knee Osteoarthritis Outcome
      Score) Quality of Life(QoL) subscore as the primary outcome and clinical examinations,
      functional tests and standing radiographs (Kellgren Lawrence method) as secondary outcome
      measurements. Those assesments will be measured after 1,2 and 5 years after the operation.

      Hypothesis:

      There are no difference between the two methods as judged by the KOOS QoL subscore.

      Questions to be answered:

      Is there a difference between double-bundle and single-bundle technique in the subjective
      outcome scores as measured by the KOOS score? Are there differences between hamstrings single
      bundle and double bundle technique when the Lachman test and the pivot shift test are being
      used? Is there a difference between hamstrings double-bundle technique and single-bundle
      technique in return to sports and activity level? Are there differences between double-bundle
      technique and single -bundle technique in functional tests (one-leg hop test)? Is there a
      difference in the development of osteoarthritis between the two techniques?
    

Intervention name(s): Single bundle; Double bundle
Intervention type(s): Procedure; Procedure
Intervention description(s): 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:
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.
Other intervention name(s): Endobutton; Endobutton
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: double bundle; hamstring graft; ACL reconstruction; single bundle