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Clinical Trials/NCT02833454
NCT02833454
Unknown
Not Applicable

Anterior Cruciate Ligament Reconstruction (ACLR) Using Direct Insertion Technique or Traditional Technique With Single and Double Bundle Procedure.

Peking University Third Hospital0 sites320 target enrollmentJuly 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rupture of Anterior Cruciate Ligament
Sponsor
Peking University Third Hospital
Enrollment
320
Primary Endpoint
Tegner score of the knee
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2016
End Date
August 2018
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jia-kuo yu

Professor

Peking University Third Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Tegner score of the knee

Time Frame: two years

Tegner score of the knee was evaluated preoperatively and at 2 years post operation . Scale name:score

Lysholm score of the knee

Time Frame: two years

Lysholm score of the knee was evaluated preoperatively and at 2 years post operation . Scale name:score

IKDC score of the knee

Time Frame: two years

IKDC score of the knee was evaluated preoperatively and at 2 years post operation . Scale name:score

Secondary Outcomes

  • KT-2000 of the knee(two years)

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