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

Ruptured Achilles Tendon Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04114708
• Other study ID #: 19-01185
• Status: Withdrawn
• Phase: N/A
• Start date: January 2022
• Est. completion date: October 2022

Study information

• Verified date: July 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Ruptured Achilles Tendon

Intervention

Diagnostic Test:
• Anterior cruciate ligament Reconstruction (ACLR)
All patients will undergo an anatomic ACLR via a standardized fashion using BTB autograft.
• 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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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