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

Anterior Cruciate Ligament Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05962580
• Other study ID #: MD 13/2021
• Status: Completed
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: July 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 1, 2023
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Tear

Intervention

Procedure:
• Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesis
Anatomical single bundle ACLR with modified Lemiere technique
• Isolated anterior cruciate ligament reconstruction only
arthroscopic anatomical single bundle ACL Reconstruction

Locations

Country	Name	City	State
Egypt	Ahmed Abdel Salam Abdel Halim	Cairo	Abbasia

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	failure rate	retear of ACL graft confirmed by clinical examination and MRI	one year follow up
Secondary	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
Secondary	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
Secondary	antero-posterior instability measure	measure AP instability by KT1000 lachmeter for injured and non injured knee	at 3,6,9 and 12 months
Secondary	side to side KT 1000 lachmeter difference	measure side to side KT 1000 lachmeter difference by (injured - noninjured)	one year follow up