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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04114708
Enrollment
0
Registered
2019-10-03
Start date
2022-01-31
Completion date
2022-10-31
Last updated
2022-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ruptured Achilles Tendon

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.

Interventions

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

DIAGNOSTIC_TESTACLR 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.

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to 25 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Determine if ACLR supplementation with LET results in superior MRI findings relative to ACLR alone1 YearMRI findings will be compared in patients receiving ACLR+LET versus just ACLR

Secondary

MeasureTime frameDescription
Graft Failure1 YearDefined as either symptomatic instability requiring revision or symptomatic instability with positive pivot shift or asymmetrical pivot shift greater than the contralateral side.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026