Study of the Anatomical Direct Insertion Anterior Cruciate Ligament Reconstruction

Peking University

Status: Unknown

Conditions: Rupture of Anterior Cruciate Ligament

Treatments: Procedure: double bundle anterior cruciate ligament reconstruction; Procedure: single bundle anterior cruciate ligament reconstruction; Procedure: direct insertion anterior cruciate ligament reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT02833454

DACL-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 320 estimated patients

Sex: All

Ages: 16 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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320 participants in 4 patient groups

direct insertion single bundle ACLR

Active Comparator group

Description:

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

Treatment:

Procedure: single bundle anterior cruciate ligament reconstruction

Procedure: direct insertion anterior cruciate ligament reconstruction

anatomical double bundle ACLR

Experimental group

Description:

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

Treatment:

Procedure: double bundle anterior cruciate ligament reconstruction

anatomical single bundle ACLR

Experimental group

Description:

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

Treatment:

Procedure: single bundle anterior cruciate ligament reconstruction

direct insertion double bundle ACLR

Active Comparator group

Description:

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

Treatment:

Procedure: double bundle anterior cruciate ligament reconstruction

Procedure: direct insertion anterior cruciate ligament reconstruction