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

• Sponsor: Ain Shams University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05962580
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 24.4
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anterior Cruciate Ligament Tear	Procedure: Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesis; Procedure: Isolated anterior cruciate ligament reconstruction only	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: of Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-Articular Tenodesis Between High Demand Patients: Randomized Controlled Trial
• Actual Study Start Date: Feb 15, 2021
• Actual Primary Completion Date: Feb 15, 2022
• Actual Study Completion Date: Mar 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. failure rate [one year follow up]

   retear of ACL graft confirmed by clinical examination and MRI

Secondary Outcome Measures

1. International knee documentation committee score (IKDC) [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 [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 [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 [one year follow up]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmed Abdel Salam Abdel Halim	Cairo	Abbasia	Egypt	11539

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ain Shams University
• ClinicalTrials.gov Identifier: NCT05962580
• Other Study ID Numbers: MD 13/2021
• First Posted: Jul 27, 2023
• Last Update Posted: Jul 27, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ain Shams University: anterior cruciate ligament tear; anterolateral instability; retear; extra articular tenodesis
• Additional relevant MeSH terms: Anterior Cruciate Ligament Injuries

Study Results

No Results Posted as of Jul 27, 2023