SEQUAR SEmitendinosus vs QUadriceps in Anterior Cruciate Ligament Reconstruction

Summary

Participation Requirements

Description

The purpose of the study is to evaluate the quadriceps graft with bone-plug in Anterior Cruciate Ligament Reconstruction (ACL-R) and compare it with Sweden's standard choice of graft, semitendinosus graft in ACL-R in higher level athletes with Tegner Activity Scale 7 or higher. Both methods are well...

The purpose of the study is to evaluate the quadriceps graft with bone-plug in Anterior Cruciate Ligament Reconstruction (ACL-R) and compare it with Sweden's standard choice of graft, semitendinosus graft in ACL-R in higher level athletes with Tegner Activity Scale 7 or higher. Both methods are well-known and continually registered in the Swedish ACL Registry. Patients will be followed up during a 2-year period. Both grafts will be compared post operatively as to laxity, PROM, as well as measure graft site morbidity, Return to Sports rate, and the post-operative rehab. At 9 months we will also preform a MRI scan to determine graft maturity. 5-year and 10-year data will also be acquired through the Swedish ACL-registry and Lysholm score and Tegner Activity Level score. At 10-year a plain weight baring X-ray will be preformed to evaluate development of osteoarthritis.Both methods are well-known and continually registered in the Swedish ACL Registry. The study design is a prospective randomized study with equal groups: Semitendinosus graft (=100) and Quadriceps tendon graft (n=100). According to historical material from Capio Artro Clinic (Stockholm) the following power calculation has been made: Significance lever 5 percent (p=0.05) and power is 80%. The difference between the groups is 1 mm knee laxity with KT-1000 which would give an effect size of 0,44 or less compared to an average effect size (0,50). 85 individuals will be needed in each group in the statistical analysis. Stratifying according to gender will be done with 40% female and 60 % males, as this represent the prevalence of ACL reconstruction in our clinic and in the Swedish ACL registry. It is known the females have a higher rerupture rate and lower subjective outcome. Inclusion will continue until we have 100 individuals in each group according to the stratification. This means that each group can have more than 100 individuals. Randomization process and study design will be done according to the CONSORT guidelines.

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