Anterior Cruciate Ligament Tear Clinical Trial
Official title:
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
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).
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.
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