Comparative Study of the Inclination Angle and Complications of Eccentric Grafts Position in ACL Reconstruction and Normal ACL: Retrospective Cohort

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

Comparative Study of the Inclination Angle and Complications of Eccentric Grafts Position in ACL Reconstruction and Normal ACL: Retrospective Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04188704
• Other study ID #: MTU-EC-OT-1-182/60
• Status: Completed
• Phase: N/A
• Start date: January 1, 2013
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2019
• Source: Ramathibodi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The anatomic ACL reconstruction aims at functional restoration of the ACL to its native dimensions, collagen orientation and insertion sites. Even if the anatomic foot prints are correctly chosen for the tibial and femoral tunnels does the position of interference screw in the tibial tunnel alter the ACL orientation? The study hypothesized that the position of interference screw in the tibial tunnel would alter the graft orientation in anatomic ACL reconstruction. The purpose of this study was to compare graft orientation and inclination angle with posterolateral and anteromedial interference screw position in tibial tunnel in aperture fixation techniques.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• magnetic resonance imaging (MRI) of patients with ACL reconstruction was compared to MRI in which ACL was intact.

• patients with isolated ACL injury who underwent ACL reconstruction surgery using quadripled hamstrings graft and operated by a single senior surgeon

• Both pre-operative and post-operative MRI should be available for assessment

• No history of trauma in the post-operative or rehabilitation period

Exclusion Criteria:

• Concomitant bony or other ligament injury to the same knee

• history of previous surgery to the same knee

• Revision ACL reconstruction surgery

• surgery done at other center or by other doctors at our institute

• Pre-operative and/or post-operative MRI not available

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries

Intervention

Procedure:
• Interference screw
Anterior cruciate ligament reconstruction (anterior screw fixation or posterior screw fixation)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ramathibodi Hospital	Thammasat University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inclination angle	Mean anterior cruciate ligament inclination angle in sagital x-ray (degree)	6 months
Secondary	post-operative complications	number of participants with revision, infection, reflex sympathetic dystrophy and re-rupture	6 months