MRI Review of ACLR With and Without Lateral Extra-articular Tenodesis

Study Overview
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Brief Summary
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The purpose of the proposed study is to evaluate the effect of lateral extra-articular tenodesis (LET) on anterior cruciate ligament reconstruction through evaluation of postoperative magnetic resonance imaging (MRI). This will be a single-center non-randomized controlled study. The study is comparing postoperative graft MRI findings in two cohorts: patients undergoing isolated ACLR and patients undergoing ACLR with lateral extra-articular tenodesis (LET). Postoperative MRIs will be obtained at 6, 9 and 12 months postoperatively.

Official Title
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MRI Review of ACLR With and Without Lateral Extra-articular Tenodesis

Conditions
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Ruptured Achilles Tendon

Intervention / Treatment
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* Diagnostic Test: Anterior cruciate ligament Reconstruction (ACLR)
* Diagnostic Test: ACLR with lateral extra-articular tenodesis (LET)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ACL deficient knee skeletally mature (as defined by closed growth plates on plain radiograph) at least 13 years of age less than 26 years of age not pregnant two or more of following criteria: competitive pivoting sport, grade 2 pivot shift or - greater, generalized ligament laxity (beighton score of 4 or greater ) no concomitant lateral meniscus tear Exclusion Criteria: knee with intact ACL skeletally immature (as defined by open physis on plain radiograph) less than two of following criteria: competitive pivoting sport, grade 2 pivot shift or - greater, generalized ligament laxity (beighton score of 4 or greater ) pregnant less than 13 years of age older than age 25 previous ACL repair concomitant lateral meniscus tear unable to speak english or perform informed consent multiligamentous knee injury (two or more ligaments requiring surgical attention) varus or valgus malalignment greater than 3 degrees

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ACLR<br>All patients will undergo an anatomic ACLR via a standardized fashion using BTB autogaft graft. | Diagnostic Test: Anterior cruciate ligament Reconstruction (ACLR)<br>* All patients will undergo an anatomic ACLR via a standardized fashion using BTB autograft.<br>|
| Other: ACLR with lateral extra-articular tenodesis<br>All LETs will be performed in a standardized fashion using the modified Lameire technique. | Diagnostic Test: ACLR with lateral extra-articular tenodesis (LET)<br>* All LETs will be performed in a standardized fashion using the modified Lameire technique. All patients will undergo an anatomic ACLR via a standardized fashion using BTB autogaft graft.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine if ACLR supplementation with LET results in superior MRI findings relative to ACLR alone | MRI findings will be compared in patients receiving ACLR+LET versus just ACLR | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft Failure | Defined as either symptomatic instability requiring revision or symptomatic instability with positive pivot shift or asymmetrical pivot shift greater than the contralateral side. | 1 Year |