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

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.

Study Overview

• Status: Withdrawn
• Conditions: Ruptured Achilles Tendon
• Intervention / Treatment: Diagnostic test: Anterior cruciate ligament Reconstruction (ACLR); Diagnostic test: ACLR with lateral extra-articular tenodesis (LET)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Michael Alaia, MD, New York Langone Health

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Actual): July 8, 2022
• Last Update Submitted That Met QC Criteria: July 5, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 19-01185

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: Requests should be directed to david.bloom@nyulangone.org To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No