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

Not Applicable

Withdrawn

• Conditions: Ruptured Achilles Tendon
• Interventions: Diagnostic Test: ACLR with lateral extra-articular tenodesis (LET); Diagnostic Test: Anterior cruciate ligament Reconstruction (ACLR)

• Registration Number: NCT04114708
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-24
• Study First Submitted QC: 2019-10-01
• Study First Posted: 2019-10-03
• Study Start: 2022-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-05
• Last Update Posted: 2022-07-08
• Primary Completion: 2022-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Determine if ACLR supplementation with LET results in superior MRI findings relative to ACLR alone	1 Year	MRI findings will be compared in patients receiving ACLR+LET versus just ACLR

Secondary Outcome Measures

Name	Time	Method
Graft Failure	1 Year	Defined as either symptomatic instability requiring revision or symptomatic instability with positive pivot shift or asymmetrical pivot shift greater than the contralateral side.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States