Double Bundle Anterior Cruciate Ligament Reconstruction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Oslo University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01033188
First received: December 15, 2009
Last updated: July 3, 2011
Last verified: November 2009
  Purpose

There has been an increased awareness in ACL 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 70% at 7-year follow-up 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.


Condition Intervention
Knee Instability
Procedure: Single Bundle
Procedure: double bundle

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • KOOS score(QOL) [ Time Frame: 1-5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Standing radiographs (Kellgren Lawrence methode) [ Time Frame: 3-5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: November 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: single-bundle technique Procedure: Single Bundle

Procedure:

Transarthroscopic technique with medial portal placement of the femoral tunnel (45, 46). 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 at 9.30- 10 o'clock in the left knee and 2-2.30 in the right knee. The graft will be fixed with an Endobutton on the femur and with an RCI screw in the tibia with approximately 4 kegs of graft pretension and with the knee close to extension. Prior to the final fixation, the knee will be taken through 20 flexion and extension movements.The surgery will be carried out by an experienced knee surgeon.

Other Name: Endo-button
Active Comparator: Double-bundle technique 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 and Nephew drill guide. The graft will be fixed with 2 Endobuttons on the femur and with 2 RCI screws in the tibia with approximately 4 kgs of graft pretension. 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 and the AM bundle with the knee in approximately 45 degrees of flexion. The surgery will be carried out by an experienced knee surgeon.

Other Name: Endo-button

Detailed Description:

The goal of this study:

The goal is to compare the two techniques: single bundle hamstrings versus double bundle hamstrings using the KOOS score as the primary variable and clinical examinations and standing radiographs (Kellgren Lawrence method) after 1,2 and 5 years as secondary variables.

Hypothesis:

There are no differences between the two methods as judged by the KOOS score (QOL).

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?

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinically verified ACL rupture (history, Lachman test 2+ or more with no endpoint; pos pivot shift and arthroscopically verifies) The Gracilis-graft has to be 5,5mm or larger.

Exclusion Criteria:

  • PCL injury,
  • ACL injury to the contra lateral knee
  • > 1+ medial or lateral-posterolateral ligament injury
  • Previous ACL reconstruction
  • Meniscal injury leaving < 50% of the meniscus intact
  • Established OA as judged by Kellgren 3-4.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01033188

Contacts
Contact: Lars MD Bjune 0047 22118080 bjzl@uus.no

Locations
Norway
Ullevaal University Hospital Recruiting
Oslo, Norway
Contact: Bjune, MD       bjzl@uus.no   
Sub-Investigator: Lars Engebretsen, MD, Phd         
Sponsors and Collaborators
Ullevaal University Hospital
Investigators
Study Chair: Lars Engebretsen, Phd, MD Supervisor
  More Information

No publications provided

Responsible Party: Prof. Lars Engebretsen, Ullevål Universitetssykehus
ClinicalTrials.gov Identifier: NCT01033188     History of Changes
Other Study ID Numbers: 6.2009.234
Study First Received: December 15, 2009
Last Updated: July 3, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

ClinicalTrials.gov processed this record on April 17, 2014