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NCT Number: NCT05962580

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

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

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Key information

Conditions

Anterior Cruciate Ligament Tear Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ahmed Abdel Salam Abdel Halim

Cairo, Abbasia, 11539, Egypt

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • History of knee traumatic event.
  • Clinical examination ( positive Lachman test and pivot shift test).
  • 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.

Treatment and study plan

Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesis

Procedure

Anatomical single bundle ACLR with modified Lemiere technique

Isolated anterior cruciate ligament reconstruction only

Procedure

arthroscopic anatomical single bundle ACL Reconstruction

Primary outcomes

  1. failure rate

    Time frame: one year follow up

    retear of ACL graft confirmed by clinical examination and MRI

Secondary outcomes

  1. International knee documentation committee score (IKDC)

    Time frame: at 3,6,9,12 months

    The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)

  2. Lysholm score

    Time frame: at 3,6,9,12 months

    The Lysholm Knee Score calculates and grades an overall score from 0 to 100 based on 8 domains: squatting, locking, pain, stair climbing, support, instability, and edema. Physicians use this condition-specific, subjective outcome score to assess patient progress after surgery or injury to the knee. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)

  3. antero-posterior instability measure

    Time frame: at 3,6,9 and 12 months

    measure AP instability by KT1000 lachmeter for injured and non injured knee

  4. side to side KT 1000 lachmeter difference

    Time frame: one year follow up

    measure side to side KT 1000 lachmeter difference by (injured - noninjured)

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

of Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-Articular Tenodesis Between High Demand Patients: Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jul 27, 2023
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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