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

NCT ID: NCT04114708

Last Updated: 2022-07-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2022-10-31

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.

Conditions

Ruptured Achilles Tendon

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ACLR

All patients will undergo an anatomic ACLR via a standardized fashion using BTB autogaft graft.

Group Type: OTHER

Anterior cruciate ligament Reconstruction (ACLR)

Intervention Type: DIAGNOSTIC_TEST

All patients will undergo an anatomic ACLR via a standardized fashion using BTB autograft.

ACLR with lateral extra-articular tenodesis

All LETs will be performed in a standardized fashion using the modified Lameire technique.

Group Type: OTHER

ACLR with lateral extra-articular tenodesis (LET)

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

Anterior cruciate ligament Reconstruction (ACLR)

All patients will undergo an anatomic ACLR via a standardized fashion using BTB autograft.

Intervention Type: DIAGNOSTIC_TEST

ACLR with lateral extra-articular tenodesis (LET)

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.

Intervention Type: DIAGNOSTIC_TEST

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 )
• 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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Alaia, MD

Role: PRINCIPAL_INVESTIGATOR

New York Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Other Identifiers

19-01185

Identifier Type: -

Identifier Source: org_study_id