Evaluation of the Results of Two Different Methods in Management of Antero-lateral Instability of the Knee

This randomized clinical study will be conducted to compare the results of anterior cruciate ligament reconstruction (ACLR) combined with either anterolateral ligament reconstruction using peroneus longus autograft or extra-articular tenodesis (Modified Lemaire) in management of antero-lateral instability of the knee

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Injuries
• Intervention / Treatment: Procedure: ACL reconstruction combined with anterolateral ligament reconstruction using peroneus longus autograft; Procedure: ACL reconstruction combined with extra-articular tenodesis (Modified Lemaire)

Detailed Description

Patients will undergo an anatomic ACLR in a standardized fashion by the same team of surgeons. They are randomly divided into 2 groups either ACLR plus ALL reconstruction or ACLR combined with LET in a 1:1 ratio. There are multiple graft options for ACL-R, but here for the study, the hamstring autograft is harvested following the traditional technique. The graft is measured and bony tunnels are drilled. An anatomical reconstruction technique is used in all cases.

In group A: the surgeon will harvest peroneus longus graft, then sutured to the double bundle hamstring graft. The graft diameters are measured and recorded. The graft is pulled through the femoral tunnel and passed through the tibial tunnel. The single portion of the graft is passed freely through the tibial and femoral tunnels until the quintuple graft portion occupies both tunnels. The graft is then pulled, and an interference screw (Smith & Nephew Endoscopy) is fixed to the femur. The next step is to fix the inferior end of the quintuple graft to the tibia after pre-tensioning. After tibial fixation, the remaining PL is passed through the subcutaneous and ALL tunnels. The ligament is fixed under traction, mild valgus stress, and 30' of flexion 1.5 cm from the joint line into a midpoint between Gerdy's tubercle and the fibular head.

In group B: the surgeon will use a triple STG hamstring (6- strands) tendon graft. The graft diameters are measured and recorded.

Then, LET is performed in a standardized fashion as described in the modified Lemaire technique. LET is fixed with interference screws (Smith & Nephew Endoscopy). Femoral and tibial fixations are performed with bio-absorbable interference screws (Smith & Nephew Endoscopy).

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Omar Abdelkarim, Master; Phone Number: 01008016681; Email: omar.ortho89@gmail.com
• Study Contact Backup: Name: Mohamed Ali, MD; Phone Number: 01011954560; Email: mohamed.ali@yahoo.com

Study Locations

• Egypt
  • Sohag, Egypt
    • Recruiting
    • Sohag University
    • Contact: Mohamed Ali, MD; Phone Number: 01011954560; Email: omar_smsa@yahoo.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. The ACL deficient knee was clinically manifested by physical examination and confirmed by MRI.
2. Age 18-45 years, skeletally mature patient.
3. A positive pivot shift test of at least grade II is required (significant anterolateral instability).

Exclusion Criteria:

1. Multiple ligament injuries or a polytraumatized patient
2. Revision cases.
3. Generalized laxity.
4. Symptomatic articular cartilage defect requiring treatment; Outerbridge > grade II.
5. More than three degrees of varus or valgus malalignment

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Reconstruction group; Patients with ACL injury and antero-lateral knee instability undergo ACL reconstruction combined with anterolateral ligament reconstruction using peroneus longus autograft	Procedure: ACL reconstruction combined with anterolateral ligament reconstruction using peroneus longus autograft; ACL reconstruction combined with anterolateral ligament reconstruction using peroneus longus autograft
Active Comparator: Tenodesis group; Patients with ACL injury and antero-lateral knee instability undergo ACL reconstruction combined with extra-articular tenodesis (Modified Lemaire).	Procedure: ACL reconstruction combined with extra-articular tenodesis (Modified Lemaire); ACL reconstruction combined with extra-articular tenodesis (Modified Lemaire)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional results of knee stability and return to normal activity	IKDC (International Knee Documentation Committee) subjective knee evaluation form	12 months postoperatively

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Study Chair: Abdelrahman Hafez, MD, PROFESSOR

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: January 1, 2024
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Actual): January 25, 2024

Study Record Updates

• Last Update Posted (Actual): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: Soh-Med-23-12-12MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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