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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesis

Isolated anterior cruciate ligament reconstruction only

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Tear focused on measuring anterior cruciate ligament tear, anterolateral instability, retear, extra articular tenodesis

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept 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: 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.

Sites / Locations

Ahmed Abdel Salam Abdel Halim

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Isolated anterior cruciate ligament recnostruction with lateral extra articular tenodesis

Isolated anterior cruciate ligament recnostruction without lateral extra articular tenodesis

Arm Description

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

Arthroscopic anatomical single bundle anterior cruciate ligament reconstruction only

Outcomes

Primary Outcome Measures

failure rate

retear of ACL graft confirmed by clinical examination and MRI

Secondary Outcome Measures

International knee documentation committee score (IKDC)

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)

Lysholm score

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)

antero-posterior instability measure

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

side to side KT 1000 lachmeter difference

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

Full Information

NCT ID

NCT05962580

First Posted

July 6, 2023

Last Updated

July 25, 2023

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT05962580

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

February 15, 2021 (Actual)

Primary Completion Date

February 15, 2022 (Actual)

Study Completion Date

March 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

Brief Summary

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

Detailed 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anterior Cruciate Ligament Tear

Keywords

anterior cruciate ligament tear, anterolateral instability, retear, extra articular tenodesis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Isolated anterior cruciate ligament recnostruction with lateral extra articular tenodesis

Arm Type

Experimental

Arm Description

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

Arm Title

Isolated anterior cruciate ligament recnostruction without lateral extra articular tenodesis

Arm Type

Active Comparator

Arm Description

Arthroscopic anatomical single bundle anterior cruciate ligament reconstruction only

Intervention Type

Procedure

Intervention Name(s)

Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesis

Intervention Description

Anatomical single bundle ACLR with modified Lemiere technique

Intervention Type

Procedure

Intervention Name(s)

Isolated anterior cruciate ligament reconstruction only

Intervention Description

arthroscopic anatomical single bundle ACL Reconstruction

Primary Outcome Measure Information:

Title

failure rate

Description

retear of ACL graft confirmed by clinical examination and MRI

Time Frame

one year follow up

Secondary Outcome Measure Information:

Title

International knee documentation committee score (IKDC)

Description

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)

Time Frame

at 3,6,9,12 months

Title

Lysholm score

Description

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)

Time Frame

at 3,6,9,12 months

Title

antero-posterior instability measure

Description

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

Time Frame

at 3,6,9 and 12 months

Title

side to side KT 1000 lachmeter difference

Description

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

Time Frame

one year follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amr Mo Abdelhady, Professor

Organizational Affiliation