NCT04114708

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 3, 2019

Completed
2.2 years until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

July 8, 2022

Status Verified

July 1, 2022

Enrollment Period

9 months

First QC Date

September 24, 2019

Last Update Submit

July 5, 2022

Conditions

Ruptured Achilles Tendon

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Graft Failure

    1 Year

Study Arms (2)

ACLR

OTHER

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

Diagnostic Test: Anterior cruciate ligament Reconstruction (ACLR)

ACLR with lateral extra-articular tenodesis

OTHER

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

Diagnostic Test: ACLR with lateral extra-articular tenodesis (LET)

Interventions

Anterior cruciate ligament Reconstruction (ACLR)DIAGNOSTIC_TEST

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

ACLR
ACLR with lateral extra-articular tenodesis (LET)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.

ACLR with lateral extra-articular tenodesis

Eligibility Criteria

Age13 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Study Officials

  • Michael Alaia, MD

    New York Langone Health

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2019

First Posted

October 3, 2019

Study Start

January 1, 2022

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

July 8, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Shared Documents
SAP
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.
Access Criteria
Requests should be directed to david.bloom@nyulangone.org To gain access, data requestors will need to sign a data access agreement.

Locations

US(1)