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

NCT04114708 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-07-08

No results posted yet for this study

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.

Conditions

  • Ruptured Achilles Tendon

Interventions

DIAGNOSTIC_TEST

Anterior cruciate ligament Reconstruction (ACLR)

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

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.

Sponsors & Collaborators

Principal Investigators

  • Michael Alaia, MD · New York Langone Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2022-10-31
Completion
2022-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04114708 on ClinicalTrials.gov