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

NCT ID: NCT06222814

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-08-31

Brief Summary

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

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).

Conditions

Anterior Cruciate Ligament Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Reconstruction group

Patients with ACL injury and antero-lateral knee instability undergo ACL reconstruction combined with anterolateral ligament reconstruction using peroneus longus autograft

Group Type: ACTIVE_COMPARATOR

ACL reconstruction combined with anterolateral ligament reconstruction using peroneus longus autograft

Intervention Type: PROCEDURE

ACL reconstruction combined with anterolateral ligament reconstruction using peroneus longus autograft

Tenodesis group

Patients with ACL injury and antero-lateral knee instability undergo ACL reconstruction combined with extra-articular tenodesis (Modified Lemaire).

Group Type: ACTIVE_COMPARATOR

ACL reconstruction combined with extra-articular tenodesis (Modified Lemaire)

Intervention Type: PROCEDURE

ACL reconstruction combined with extra-articular tenodesis (Modified Lemaire)

Interventions

ACL reconstruction combined with anterolateral ligament reconstruction using peroneus longus autograft

ACL reconstruction combined with anterolateral ligament reconstruction using peroneus longus autograft

Intervention Type: PROCEDURE

ACL reconstruction combined with extra-articular tenodesis (Modified Lemaire)

ACL reconstruction combined with extra-articular tenodesis (Modified Lemaire)

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Omar Mohamed Abdelkareem

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdelrahman Hafez, MD

Role: STUDY_CHAIR

Professor

Locations

Sohag University

Sohag, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Omar Abdelkarim, Master

Role: CONTACT

omar.ortho89@gmail.com

01008016681

Mohamed Ali, MD

Role: CONTACT

mohamed.ali@yahoo.com

01011954560

Facility Contacts

Mohamed Ali, MD

Role: primary

omar_smsa@yahoo.com

01011954560

Other Identifiers

Soh-Med-23-12-12MS

Identifier Type: -

Identifier Source: org_study_id