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

NYU Langone Health logo

NYU Langone Health

Status

Withdrawn

Conditions

Ruptured Achilles Tendon

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04114708
19-01185

Details and patient eligibility

About

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.

Sex

All

Ages

13 to 25 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

ACLR
Other group
Description:
All patients will undergo an anatomic ACLR via a standardized fashion using BTB autogaft graft.
Treatment:
Diagnostic Test: Anterior cruciate ligament Reconstruction (ACLR)
ACLR with lateral extra-articular tenodesis
Other group
Description:
All LETs will be performed in a standardized fashion using the modified Lameire technique.
Treatment:
Diagnostic Test: ACLR with lateral extra-articular tenodesis (LET)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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