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

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

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

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Tear
• Intervention / Treatment: Procedure: Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesis; Procedure: Isolated anterior cruciate ligament reconstruction only

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)

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Abbasia
    • Cairo, Abbasia, Egypt, 11539
      • Ahmed Abdel Salam Abdel Halim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesis; Anatomical single bundle ACLR with modified Lemiere technique
Active Comparator: Isolated anterior cruciate ligament recnostruction without lateral extra articular tenodesis; Arthroscopic anatomical single bundle anterior cruciate ligament reconstruction only	Procedure: Isolated anterior cruciate ligament reconstruction only; arthroscopic anatomical single bundle ACL Reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
failure rate	retear of ACL graft confirmed by clinical examination and MRI	one year follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	at 3,6,9,12 months
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)	at 3,6,9,12 months
antero-posterior instability measure	measure AP instability by KT1000 lachmeter for injured and non injured knee	at 3,6,9 and 12 months
side to side KT 1000 lachmeter difference	measure side to side KT 1000 lachmeter difference by (injured - noninjured)	one year follow up

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Chair: Amr Mo Abdelhady, Professor, Faculty of medecine, Ain shams university; Study Director: Mohamed Ha Sobhey, Professor, Faculty of medecine, Ain shams university; Study Director: Moustapha Al ElAbd, lecturer, Faculty of medecine, Ain shams university; Study Director: Yehia Mo Haroun, Lecturer, Faculty of medecine, Ain shams university; Principal Investigator: Ahmed Ab Amer, Msc, Faculty of medecine, Ain shams university

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Actual): February 15, 2022
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: July 25, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: retear; anterior cruciate ligament tear; anterolateral instability; extra articular tenodesis
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: MD 13/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No