SEQUAR SEmitendinosus vs QUadriceps in Anterior Cruciate Ligament Reconstruction

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 the most common choice of graft, semitendinosus hamstrings graft in ACL-R in athletes with Tegner Activity Scale 7 or higher. Both methods are well-known and continually registered in the Swedish ACL Registry.

Both grafts will be compared post operatively as to knee laxity (primary outcome), PROMs, 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.

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. Although no stratification for sex will be performed, our aim is to have a balanced representation of sex that reflects the typical patient population for this condition at the clinic, with a distribution of 40% females and 60% males across both groups. Inclusion will continue until we have at least 100 individuals in each group. This means that each group can have more than 100 individuals. Randomization process and study design will be done according to the CONSORT guidelines.

Initially, the study was designed to have two primary outcome measures: KT-1000 knee laxity at 6 months and KOOS at 24 months. However, the study is only powered for the first outcome (Knee Laxity measured with KT-1000), therefore KOOS will be followed as a secondary outcome measure.

• KOOS [Time frame: Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments]
• IKDC [Time frame: Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments]
• PAS [Time frame: Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments]
• EQ5D [Time frame: Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments]
• Tegner Activity Score [Time frame: Pre-operative appointment, 6 months, 9 months, 12 months, 18 months, 24 months, 5 years and 10 years post-operative appointments]
• ACL-RSI [Time frame: 6 months and 12 months, post-operative appointments]
• Return to Sports Questionnaire [Time frame: 6 months, 9 months and 12 months, 18 months, and 24 months post-operative appointments]
• Werner anterior knee pain score [Time frame: 6 weeks, 6 months, 9 months, and 12 months]
• Kartus anterior knee pain score [Time frame: 6 weeks, 6 months, 9 months, and 12 months]
• Graft site morbidity questionnaire [Time frame: 6 weeks, 6 months, 12 months, 24 months]
• Goniometric measurement: Knee extension and flexion [Time frame: 2 weeks, 6 weeks, 6 months, 9 months and 12 months]
• Measurement of circumference of the knee [Time frame: 2 weeks, 6 weeks, 6 months, 9 months and 12 months]