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

Cruciate Ligament Rupture Clinical Trial

Official title:

Biomechanical Assessment of the Reconstruction of the Anterolateral Ligament During ACL Surgery. The In-vivo Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02993679
• Other study ID #: Hospital Znojmo
• Status: Completed
• Phase: N/A
• First received: December 4, 2016
• Last updated: December 14, 2016
• Start date: July 2014
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: Hospital Znojmo
• Contact: n/a
• Is FDA regulated: No
• Health authority: prof. Hart Radek, M.D., Ph.D., FRCS: Hospital Znojmo
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 40 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cruciate Ligament Rupture
• Rupture

Intervention

Procedure:
• reconstruction of the ACL and anterolateral ligament
reconstruction of the ACL and anterolateral ligament

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Znojmo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of the change in the rotational stability of the knee joint after ACL and anterolateral ligament reconstruction.	Analyse of the rotational stability of the knee joint 24 months after the operation by the computerised navigation system.	24 months after the operation	Yes