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Clinical Trials/NCT04114708
NCT04114708
Withdrawn
Not Applicable

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

NYU Langone Health1 site in 1 countryJanuary 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ruptured Achilles Tendon
Sponsor
NYU Langone Health
Locations
1
Primary Endpoint
Determine if ACLR supplementation with LET results in superior MRI findings relative to ACLR alone
Status
Withdrawn
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2022
End Date
October 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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 )
  • 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

Outcomes

Primary Outcomes

Determine if ACLR supplementation with LET results in superior MRI findings relative to ACLR alone

Time Frame: 1 Year

MRI findings will be compared in patients receiving ACLR+LET versus just ACLR

Secondary Outcomes

  • Graft Failure(1 Year)

Study Sites (1)

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