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

NCT ID: NCT05962580

Last Updated: 2023-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-15

Study Completion Date

2023-03-01

Brief Summary

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

Detailed Description

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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)

Conditions

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Anterior Cruciate Ligament Tear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Isolated anterior cruciate ligament recnostruction with lateral extra articular tenodesis

Arthroscopic anatomical single bundle anterior cruciate ligament reconstruction with modified Lemiere technique for extra-articular tenodesis

Group Type EXPERIMENTAL

Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesis

Intervention Type PROCEDURE

Anatomical single bundle ACLR with modified Lemiere technique

Isolated anterior cruciate ligament recnostruction without lateral extra articular tenodesis

Arthroscopic anatomical single bundle anterior cruciate ligament reconstruction only

Group Type ACTIVE_COMPARATOR

Isolated anterior cruciate ligament reconstruction only

Intervention Type PROCEDURE

arthroscopic anatomical single bundle ACL Reconstruction

Interventions

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Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesis

Anatomical single bundle ACLR with modified Lemiere technique

Intervention Type PROCEDURE

Isolated anterior cruciate ligament reconstruction only

arthroscopic anatomical single bundle ACL Reconstruction

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amr Mo Abdelhady, Professor

Role: STUDY_CHAIR

Faculty of medecine, Ain shams university

Mohamed Ha Sobhey, Professor

Role: STUDY_DIRECTOR

Faculty of medecine, Ain shams university

Moustapha Al ElAbd, lecturer

Role: STUDY_DIRECTOR

Faculty of medecine, Ain shams university

Yehia Mo Haroun, Lecturer

Role: STUDY_DIRECTOR

Faculty of medecine, Ain shams university

Ahmed Ab Amer, Msc

Role: PRINCIPAL_INVESTIGATOR

Faculty of medecine, Ain shams university

Locations

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Ahmed Abdel Salam Abdel Halim

Cairo, Abbasia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MD 13/2021

Identifier Type: -

Identifier Source: org_study_id

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