Study of the Anatomical Direct Insertion Anterior Cruciate Ligament Reconstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-08-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Rupture of Anterior Cruciate Ligament

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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direct insertion single bundle ACLR

Patients with ACL rupture undergo direct insertion anterior cruciate ligament reconstruction using single bundle technique.

Group Type ACTIVE_COMPARATOR

direct insertion anterior cruciate ligament reconstruction

Intervention Type PROCEDURE

ACL reconstruction based on direct insertion of ACL.

single bundle anterior cruciate ligament reconstruction

Intervention Type PROCEDURE

anterior cruciate ligament reconstruction using single bundle technique

anatomical double bundle ACLR

Patients with ACL rupture undergo double bundle anterior cruciate ligament reconstruction.

Group Type EXPERIMENTAL

double bundle anterior cruciate ligament reconstruction

Intervention Type PROCEDURE

anterior cruciate ligament reconstruction using double bundle technique

anatomical single bundle ACLR

Patients with ACL rupture undergo single bundle anterior cruciate ligament reconstruction.

Group Type EXPERIMENTAL

single bundle anterior cruciate ligament reconstruction

Intervention Type PROCEDURE

anterior cruciate ligament reconstruction using single bundle technique

direct insertion double bundle ACLR

Patients with ACL rupture undergo direct insertion anterior cruciate ligament reconstruction using double bundle technique.

Group Type ACTIVE_COMPARATOR

direct insertion anterior cruciate ligament reconstruction

Intervention Type PROCEDURE

ACL reconstruction based on direct insertion of ACL.

double bundle anterior cruciate ligament reconstruction

Intervention Type PROCEDURE

anterior cruciate ligament reconstruction using double bundle technique

Interventions

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direct insertion anterior cruciate ligament reconstruction

ACL reconstruction based on direct insertion of ACL.

Intervention Type PROCEDURE

single bundle anterior cruciate ligament reconstruction

anterior cruciate ligament reconstruction using single bundle technique

Intervention Type PROCEDURE

double bundle anterior cruciate ligament reconstruction

anterior cruciate ligament reconstruction using double bundle technique

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ACL rupture patients aged between 16 to 40 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 infammatory or systemic disease, neuromuscular disease in the lower limbs, any recent knee infection

Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No