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

Peking University

Status: Unknown

Conditions: Rupture of Anterior Cruciate Ligament

Treatments: Procedure: double bundle ACL reconstruction; Procedure: single bundle ACL reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT02834962

ACLMRI-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 10 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ACL rupture patients aged between 10 to 50 years

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

single bundle ACLR

Experimental group

Description:

patients undergo single bundle ACL reconstruction

Treatment:

Procedure: single bundle ACL reconstruction

double bundle ACLR

Active Comparator group

Description:

patients undergo double bundle ACL reconstruction

Treatment:

Procedure: double bundle ACL reconstruction