NCT02760589

Magnetic Resonance Imaging and Functional Performance Outcome After ACL Repair With Internal Brace Technique

Clinical Evaluation After Anterior Cruciate Ligament Tears (Internal Brace Technique vs. ACL Reconstruction vs. Conservative Treatment) With Special Regard to Magnetic Resonance Imaging and Functional Performance

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 92 (actual)
• Sponsor: AUVA · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is a clinical evaluation with special regard to magnetic resonance imaging and functional performance at least one year after injury / surgery in all three groups (subjects who underwent InternalBrace surgery, subjects who underwent surgery with a semitendinosus graft and subjects who were treated conservatively).

Detailed description

Lesions of the anterior cruciate ligament (ACL) are the most common ligamentous injuries with an increasing incidence. 77% of ACL insufficient knees result in moderate to high physical limitations. Different surgical treatments have been described. ACL reconstruction with either a semitendinosus or patella tendon graft is regarded as the gold standard of operative therapy. Despite numerous studies representing good and excellent outcome after ACL reconstruction, a recent Meta-analysis of Biau et al. 2006 revealed that only 40% of patients gain full functional recovery. Since the native ACL is considered to be an important factor for the proprioceptive sensation, a removal during the reconstruction might have an adverse influence on muscular stabilisation, rehabilitation and functional performance of the knee joint. Thus a primary repair of the native ACL seems reasonable. For tears of the anterior cruciate ligament near the femoral attachment a new method of surgical treatment can be applied. The InternalBrace method by Arthrex is performed arthroscopically and involves reattaching of the ACL that has avulsed off the femoral wall using a FiberTape by Arthrex. To the authors knowledge the augmentation with FiberTape by Arthrex has not been systematically evaluated. Promising results have been presented recently using a comparable method, which showed a high patient satisfaction, faster rehabilitation and a high rate of return to pre-injury sports level. To assess the functional performance, a further aim of the study is to develop a new test battery consisting of strength tests and single-leg hop tests with the ability to distinguish between the functional performance of the injured and the uninjured leg in patients with ACL deficiency. Test batteries consisting of several hop tests has been described in the previous literature indicating a good test-retest reliability measuring lower leg performance. The functional performance is defined using the limb symmetry index in percent between each individuals lower limbs. This study aims to determine the LSI of healthy subjects using the values achieved by the subjects in the control group. A limb symmetry index (LSI) between 85% and 95% is considered sufficient for return to pivoting sports in patients after knee injury.

Conditions

• Anterior Cruciate Ligament Tear

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-05-03
• Last updated: 2018-07-02

Locations

1 site across 1 country: Austria