Study of the Anatomical Direct Insertion Anterior Cruciate Ligament Reconstruction

Not Applicable

• Conditions: Rupture of Anterior Cruciate Ligament
• Interventions: Procedure: double bundle anterior cruciate ligament reconstruction; Procedure: direct insertion anterior cruciate ligament reconstruction; Procedure: single bundle anterior cruciate ligament reconstruction

• Registration Number: NCT02833454
• Lead Sponsor: Peking University Third Hospital

Brief Summary

The purpose of the study is to study the effect of anatomical direct insertion ACL reconstruction compared with conventional anatomical ACL reconstruction.

Detailed Description

The investigators divide 320 patients with ACL rupture into 4 groups, each group has 80 patients. The operation technique is different among the groups: group A: conventional anatomical double bundle acl reconstruction, group B: conventional anatomical single bundle acl reconstruction, group DA: direct insertion double bundle acl reconstruction, group DSB: direct insertion single bundle acl reconstruction. The investigators compare the results of the patients of each group at 2 years of surgery.

Study Timeline

• Status Verified: 2016-07
• Study Start: 2016-07
• Study First Submitted: 2016-07-11
• Study First Submitted QC: 2016-07-12
• Last Update Submitted: 2016-07-13
• Study First Posted: 2016-07-14
• Last Update Posted: 2016-07-15
• Primary Completion: 2018-07
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• ACL rupture patients aged between 16 to 40 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 infammatory 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
direct insertion single bundle ACLR	single bundle anterior cruciate ligament reconstruction	Patients with ACL rupture undergo direct insertion anterior cruciate ligament reconstruction using single bundle technique.
anatomical double bundle ACLR	double bundle anterior cruciate ligament reconstruction	Patients with ACL rupture undergo double bundle anterior cruciate ligament reconstruction.
direct insertion double bundle ACLR	double bundle anterior cruciate ligament reconstruction	Patients with ACL rupture undergo direct insertion anterior cruciate ligament reconstruction using double bundle technique.
direct insertion double bundle ACLR	direct insertion anterior cruciate ligament reconstruction	Patients with ACL rupture undergo direct insertion anterior cruciate ligament reconstruction using double bundle technique.
anatomical single bundle ACLR	single bundle anterior cruciate ligament reconstruction	Patients with ACL rupture undergo single bundle anterior cruciate ligament reconstruction.
direct insertion single bundle ACLR	direct insertion anterior cruciate ligament reconstruction	Patients with ACL rupture undergo direct insertion anterior cruciate ligament reconstruction using single bundle technique.

Primary Outcome Measures

Name	Time	Method
Tegner score of the knee	two years	Tegner score of the knee was evaluated preoperatively and at 2 years post operation .; Scale name:score
Lysholm score of the knee	two years	Lysholm score of the knee was evaluated preoperatively and at 2 years post operation .; Scale name:score
IKDC score of the knee	two years	IKDC score of the knee was evaluated preoperatively and at 2 years post operation .; Scale name:score

Secondary Outcome Measures

Name	Time	Method
KT-2000 of the knee	two years	KT-2000 of the knee was evaluated preoperatively and at 2 years post operation.