ACL Reconstruction With/Without ALL Reconstruction

Centre of Postgraduate Medical Education

Status: Enrolling

Conditions: ALL; ACL Injury

Treatments: Other: ALL tenodesis; Other: ALL anatomic; Procedure: ACL reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT05461625

ACL_ALL

Details and patient eligibility

About

This study will compare Anterior Cruciate Reconstruction with or without Anterolateral Ligament Reconstruction in patients with ACL injury. The purpose of this study is evaluate if addition of ALLr to ACLr provides better clinical, radiological and laboratory outcomes.

Full description

This study compare ACL reconstruction and additional tenodesis or ALL recontruction described by Arnold. Patients will be randomized fot this tree group and surgeon will be blinded.

Anterolateral ligament reconstruction could play a role in augmenting rotational stability in the ACL-reconstructed knee and are most likely to benefit hyperlax patients, revision cases, pivoting athletes, and those with IKDC grade III pivot shifts. In our study we will would like to confirm this hypothesis.

Enrollment: 762 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• primary ACL injury

Exclusion criteria

• no informed consent to participate in the study
• age under 18 years or above 65
• multilligament injury or single plane knee instability (medial, lateral)
• another musculoskeletal disorders in lower limb
• lower limb deformity requiring axis correction below 4o or above 12.5o
• joints inflammatory diseases
• ASA score > II

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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762 participants in 3 patient groups

ACL

Sham Comparator group

Description:

Anterior cruciate ligament reconstruction without additional procedure

Treatment:

Procedure: ACL reconstruction

ACL + ALL anatomic

Active Comparator group

Description:

Anterior cruciate ligament reconstruction and anatomic anterolateral ligament reconstruction

Treatment:

Procedure: ACL reconstruction

Other: ALL anatomic

ACL + ALL tenodesis

Active Comparator group

Description:

Anterior cruciate ligament reconstruction and anterolateral ligament tenodesis

Treatment:

Procedure: ACL reconstruction

Other: ALL tenodesis