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Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-Articular Tenodesis Among High Demand Patients

A

Ain Shams University

Status

Completed

Conditions

Anterior Cruciate Ligament Tear

Treatments

Procedure: Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesis
Procedure: Isolated anterior cruciate ligament reconstruction only

Study type

Interventional

Funder types

Other

Identifiers

NCT05962580
MD 13/2021

Details and patient eligibility

About

Anterior Cruciate Ligament Reconstruction with and without Lateral Extra-Articular Tenodesis between high demand patients

Full description

It is a randomized control trial comparing between isolated anterior cruciate ligament reconstruction with and without lateral extra articular tenodesis between high demand and high risk groups with high pivot regarding failure rate (primary out come) and patient reported functions score (IKDC and Lysholm)

Enrollment

20 patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • High demand patients (manual workers, athletes,...etc.).

  • Normal average body mass index ( 18.5 - 24.9 ).

  • Age <40 years old.

  • Patients will be diagnosed as ACL tear by the following:

    1. History of knee traumatic event.
    2. Clinical examination ( positive Lachman test and pivot shift test).
    3. Radiological evidence of ACL tear by MRI.
  • patient with high pivot shift test.

Exclusion criteria

  • Generalized ligamentous laxity.
  • Other intra or extra articular knee injuries.
  • Previous ACL surgery on the affected knee.
  • Bilateral ACL injuries.
  • Significant Articular surface injury.
  • Medical comorbidities
  • Patients with malalignment ( genu varum, genu valgum or genu recurvatum )
  • Neuromuscular disorders
  • Knee arthritic changes.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

20 participants in 2 patient groups

Isolated anterior cruciate ligament recnostruction with lateral extra articular tenodesis
Experimental group
Description:
Arthroscopic anatomical single bundle anterior cruciate ligament reconstruction with modified Lemiere technique for extra-articular tenodesis
Treatment:
Procedure: Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesis
Isolated anterior cruciate ligament recnostruction without lateral extra articular tenodesis
Active Comparator group
Description:
Arthroscopic anatomical single bundle anterior cruciate ligament reconstruction only
Treatment:
Procedure: Isolated anterior cruciate ligament reconstruction only

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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