SEQUAR SEmitendinosus vs QUadriceps in Anterior Cruciate Ligament Reconstruction

Study Overview
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Brief Summary
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Randomized control trial comparing two different Anterior Cruciate Ligament (ACL) grafts in Anterior Cruciate Ligament Reconstruction: the semitendinosus hamstrings graft and the quadriceps graft. Capio Artro Clinic (Stockholm) has vast experience in ACL surgery using both semitendinosus and quadriceps grafts.

Detailed Description
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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.

Official Title
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SEQUAR - SEmitendinosus vs QUadriceps in Anterior Cruciate Ligament Reconstruction - a Prospective Randomized Study

Conditions
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Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear

Intervention / Treatment
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* Procedure: ACL Reconstruction with Semitendinosus graft
* Procedure: ACL Reconstruction with Quadriceps tendon-bone graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary ACL reconstruction for patients with Tegner score equal or higher than 7 before injury. Exclusion Criteria: Multiligament knee injury Former knee operation Former fracture Inflammatory disease More than one ligamentous injury in the same knee requiring reconstructive surgery Former ACL injury in the contralateral knee Reconstruction of ACL in the contralateral knee during the study follow up period Lack av baseline pre- or postoperative data (KT-1000, KOOS, Lysholm Score, EQ-5D) Any other situation preventing patient from participating in extensive follow up.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Semitendinosus graft<br>Participants receive the Semitendinosus Graft technique during ACL reconstruction. | Procedure: ACL Reconstruction with Semitendinosus graft<br>* Participants will undergo Anterior Cruciate Ligament Reconstruction with Semitendinosus graft<br>* Other names: Semitendinosus ACL-R;|
| Active Comparator: Quadriceps tendon-bone graft<br>Participants receive the Quadriceps Tendon-Bone Graft technique during ACL reconstruction. | Procedure: ACL Reconstruction with Quadriceps tendon-bone graft<br>* Participants will undergo Anterior Cruciate Ligament Reconstruction with Quadriceps tendon-bone graft<br>* Other names: Quad tendon-bone ACL-R;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline KT-1000 Knee Laxity at 6 months | The KT-1000 measures laxity objective- and parametrically and is a validated tool for establishing joint laxity post operatively in mm. | Pre-operative appointment and 6 months post-operative appointments | 
| Change from Baseline KOOS (the Knee Injury and Osteoarthritis Outcome Score) at 24 months | Patients will complete the KOOS surveys at pre-operatively and at 2 years time post-operatively to evaluate subjective knee function | Pre-operative appointment and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IKDC | Patients will complete the IKDC at specific time points to evaluate subjective knee function throughout treatment. | Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments | 
| PAS | Patients will complete the PAS at specific time points to evaluate subjective knee function throughout treatment | Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments | 
| KOOS | Patients will complete the KOOS at specific time points to evaluate subjective knee function throughout treatment | Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments | 
| EQ5D | Patients will complete the EQ5D at specific time points to evaluate subjective knee function throughout treatment | Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments | 
| Lysholm score | Patients will complete the Lysholm score at specific time points to evaluate subjective knee function throughout treatment | Pre-operative appointment, 6 months, 9 months, 12 months, 18 months, 24 months, 5 years and 10 years post-operative appointments | 
| Tegner Activity Score | Patients will complete the Tegner Activity score at specific time points to evaluate level of sports activity postoperatively. | Pre-operative appointment, 6 months, 9 months, 12 months, 18 months, 24 months, 5 years and 10 years post-operative appointments | 
| ACL-RSI | Patients will complete the ACL-RSI surveys at specific time points to evaluate self efficacy and readiness to return to sports throughout treatment | 6 months and 12 months, post-operative appointments | 
| Return to Sports Questionnaire | Patients will complete the a Return to Sports Questionnaire at specific time points to evaluate return to sports after 6 and 12 months throughout treatment | 6 months, 9 months and 12 months, 18 months, and 24 months post-operative appointments | 
| Werner anterior knee pain score | Patients will complete Werner anterior knee pain scores at specific time points to evaluate graft site pain/morbidity throughout treatment | 6 weeks, 6 months, 9 months, and 12 months | 
| Kartus anterior knee pain score | Patients will complete Kartus anterior knee pain score at specific time points to evaluate graft site pain/morbidity throughout treatment | 6 weeks, 6 months, 9 months, and 12 months | 
| Graft site morbidity questionnaire | Patients will complete additional survey questions at specific time points to evaluate graft site pain/morbidity throughout treatment | 6 weeks, 6 months, 12 months, 24 months | 
| Goniometric measurement: Knee extension and flexion | Patients will undergo goniometric measurement at specific time points to evaluate knee moment throughout treatment. | 2 weeks, 6 weeks, 6 months, 9 months and 12 months | 
| Measurement of circumference of the knee | Circumference of the knee will be measured at mid-patella and 15 cm above superior border of the patella. They will be compared with the contralateral knee to compare knee swelling. | 2 weeks, 6 weeks, 6 months, 9 months and 12 months | 
| Biodex Isokinetic Measurement | Patients will undergo Biodex Isokinetic measurement at specific time points to muscle strength throughout treatment. | 6 months and 12 months | 
| Functional knee tests | Patients will undergo functional knee test (ie one legged jump and crossover jump) at specific time points to evaluate functional knee movement throughout treatment. | 6 months, 9 months and 12 months | 
| Lachmans test | Patients will undergo passive accessory stability tests Lachmans test (graded 0,1,2 and 3) at specific time points to evaluate passive knee laxity throughout treatment. | Pre-operative appointment , 6 months, 9 months and 12 months | 
| Pivot shift test | Patients will undergo passive accessory stability tests pivot shift test (graded 0,1,2 and 3) at specific time points to evaluate passive knee laxity throughout treatment. | Pre-operative appointment , 6 months, 9 months and 12 months | 
| Time to Return to Sports Rates | Time to return to sports will be evaluated through Return to Sport surveys at specific time points throughout treatment | 6 months, 9 months, 12 months, 18 months, 24 months | 
| Graft failure rate or ACL re-rupture | ACL reconstruction will be evaluated by graft failure rate or ACL re-rupture during a 10 year period | 10 years | 
| ACL re-operation | ACL reconstruction will be evaluated by re-operation rate during a 10 year period | 10 years | 
| Graft maturity | Graft maturity after ACL reconstruction will be evaluated by MRI at 9 months postoperatively. | 9 months | 
| 10 year X-Ray | Development of osteoarthritis after ACL reconstruction will be evaluated by plain weight baring X-rays at 10 years. | 10 years |