Stability of the Knee Joint After Anterior Cruciate Ligament and Anterolateral Ligament Reconstruction

Not Applicable

Completed

• Conditions: Cruciate Ligament Rupture
• Interventions: Procedure: reconstruction of the ACL and anterolateral ligament

• Registration Number: NCT02993679
• Lead Sponsor: Hospital Znojmo

Brief Summary

The objective of this randomised cohort study was to evaluate the knee rotational stability after the single-bundle ACL reconstruction (SB) with addition of the ALL reconstruction and to compare it with the double-bundle ACL reconstruction technique (DB) and to analyse when the ALL is necessary to reconstruct.

Detailed Description

Background Rotational instability after the anterior cruciate ligament (ACL) injury and subsequent reconstruction may be caused by the rupture of the anterolateral structures of the knee, specifically the anterolateral ligament (ALL).

There are more techniques to improve the rotational stability of the knee. The objective of this randomised cohort study was: (1) To evaluate the knee rotational stability after the single-bundle ACL reconstruction (SB) with addition of the ALL reconstruction and to compare it with the double-bundle ACL reconstruction technique (DB). (2) To analyse when the ALL is necessary to reconstruct.

Methods 60 patients underwent the ACL reconstruction with the average age of 29.5 years. In thirty patient's knees the ACL was replaced with quadriceps muscle graft using the SB technique in combination with the ALL reconstruction by the gracilis graft (ALL group). With another thirty patients the ACL was reconstructed performing DB technique with the use of hamstring tendons (DB group). The rotational stability was studied before and after the reconstruction of the ACL in time "zero" using the computer navigation system. In the ALL group, the rotational stability was also analysed after the ALL reconstruction.

Study Timeline

• Study Start: 2014-07
• Primary Completion: 2016-07
• Study Completion: 2016-11
• Status Verified: 2016-12
• Study First Submitted: 2016-12-04
• Study First Submitted QC: 2016-12-14
• Last Update Submitted: 2016-12-14
• Study First Posted: 2016-12-15
• Last Update Posted: 2016-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• The isolated ACL lesion
• The absence of the previous surgery on the knee joint
• The body mass index (BMI) less than 30.

Exclusion Criteria

• Associated injuries of the tissue around the knee joint

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
anterolateral ligament reconstruction	reconstruction of the ACL and anterolateral ligament	surgical reconstruction of the anterolateral ligament
double-bundle ACL reconstruction	reconstruction of the ACL and anterolateral ligament	surgical reconstruction of the anterior cruciate ligament

Primary Outcome Measures

Name	Time	Method
Description of the change in the rotational stability of the knee joint after ACL and anterolateral ligament reconstruction.	24 months after the operation	Analyse of the rotational stability of the knee joint 24 months after the operation by the computerised navigation system.