Study of Single And Double Bundle Anterior Cruciate Ligament (ACL) Graft Cross-sectional Dimensions

Not Applicable

• Conditions: Rupture of Anterior Cruciate Ligament
• Interventions: Procedure: single bundle ACL reconstruction; Procedure: double bundle ACL reconstruction

• Registration Number: NCT02834962
• Lead Sponsor: Peking University Third Hospital

Brief Summary

To study the difference between single and double bundle ACL graft cross-sectional dimensions compared with native ACL using postoperative 3-D MRI.

Detailed Description

The investigators divide 100 patients with ACL rupture into 2 groups. Group A undergo single bundle anterior cruciate ligament reconstruction (ACLR). Group B undergo double bundle ACL reconstruction. At 3-6 weeks post operation, all the patients undergo 3-D MRI examination of both knees. The investigators reconstruct 3-D models of reconstructed ACL and native ACL, and compare the difference between single and double bundle graft.

Study Timeline

• Status Verified: 2016-07
• Study Start: 2016-07
• Study First Submitted: 2016-07-13
• Study First Submitted QC: 2016-07-13
• Last Update Submitted: 2016-07-14
• Study First Posted: 2016-07-15
• Last Update Posted: 2016-07-18
• Primary Completion: 2017-07
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• ACL rupture patients aged between 10 to 50 years

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Exclusion Criteria

• combined severe injuries to the operated knee (additional ligament rupture, major meniscus loss, patella instability, cartilage damage >2°, pathologic leg axis deviation)
• any injury or surgery to the contralateral knee
• any inflammatory or systemic disease, neuromuscular disease in the lower limbs,any recent knee infection

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
single bundle ACLR	single bundle ACL reconstruction	patients undergo single bundle ACL reconstruction
double bundle ACLR	double bundle ACL reconstruction	patients undergo double bundle ACL reconstruction

Primary Outcome Measures

Name	Time	Method
cross-sectional area of the reconstructed ACL	3-6 weeks
long axis of the cross-sectional area of the reconstructed ACL	3-6 weeks
long to short axis ratio of the cross-sectional area of the reconstructed ACL	3-6 weeks
short axis of the cross-sectional area of the reconstructed ACL	3-6 weeks