Double Bundle Anterior Cruciate Ligament Reconstruction
There has been an increased awareness in ACL (anterior cruciate ligament) injuries for Norwegian teams, particularly in handball and soccer. The overall number of ACL tears in the United States has been reported to be between 95,000 to 200,000 annually. In accordance with these numbers, 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% in some 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Single Bundle or Double Bundle Anterior Cruciate Ligament Reconstruction. A Randomized, Controlled Trial.|
- KOOS score(QOL) [ Time Frame: 1-5 years ] [ Designated as safety issue: No ]
- Standing radiographs (Kellgren Lawrence methode) [ Time Frame: 3-5 years ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Single-bundle technique
Anatomic single-bundle technique
Procedure: Single Bundle
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.
Other Name: Endobutton
Active Comparator: Double-bundle technique
Anatomic double bundle technique
Procedure: double bundle
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 Name: Endobutton
The goal of this study:
The goal is to compare the two techniques: single bundle hamstrings versus double bundle hamstrings using the KOOS (Knee Osteoarthritis Outcome Score) as the primary variable and clinical examinations and standing radiographs (Kellgren Lawrence method) after 1,2 and 5 years as secondary variables.
There are no differences between the two methods as judged by the KOOS score (QOL, Quality of Life subscore).
Questions to be answered:
Is there a difference between double-bundle and single-bundle technique in 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? Are there differences between double-bundle technique and single -bundle technique in functional tests (one-leg hop and tre leg side jump)? Is there a difference in the development of osteoarthritis between the two techniques?
Please refer to this study by its ClinicalTrials.gov identifier: NCT01033188
|Contact: Cathrine Aga, MD||+47 email@example.com|
|Ullevaal University Hospital||Recruiting|
|Contact: Aga, MD firstname.lastname@example.org|
|Sub-Investigator: Lars Engebretsen, MD, Phd|
|Study Chair:||Lars Engebretsen, Phd, MD||Supervisor|