Study of the Anatomical Direct Insertion Anterior Cruciate Ligament Reconstruction

July 13, 2016 updated by: Jia-kuo yu, Peking University Third Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: direct insertion single bundle ACLR
Patients with ACL rupture undergo direct insertion anterior cruciate ligament reconstruction using single bundle technique.
Procedure: direct insertion anterior cruciate ligament reconstruction
ACL reconstruction based on direct insertion of ACL.
Procedure: single bundle anterior cruciate ligament reconstruction
anterior cruciate ligament reconstruction using single bundle technique
Experimental: anatomical double bundle ACLR
Patients with ACL rupture undergo double bundle anterior cruciate ligament reconstruction.
Procedure: double bundle anterior cruciate ligament reconstruction
anterior cruciate ligament reconstruction using double bundle technique
Experimental: anatomical single bundle ACLR
Patients with ACL rupture undergo single bundle anterior cruciate ligament reconstruction.
Procedure: single bundle anterior cruciate ligament reconstruction
anterior cruciate ligament reconstruction using single bundle technique
Active Comparator: direct insertion double bundle ACLR
Patients with ACL rupture undergo direct insertion anterior cruciate ligament reconstruction using double bundle technique.
Procedure: direct insertion anterior cruciate ligament reconstruction
ACL reconstruction based on direct insertion of ACL.
Procedure: double bundle anterior cruciate ligament reconstruction
anterior cruciate ligament reconstruction using double bundle technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
two years
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
two years
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
two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KT-2000 of the knee
Time Frame: two years
KT-2000 of the knee was evaluated preoperatively and at 2 years post operation.
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Study Chair: Jia-Kuo Yu, MD, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

July 11, 2016

First Submitted That Met QC Criteria

July 12, 2016

First Posted (Estimate)

July 14, 2016

Study Record Updates

Last Update Posted (Estimate)

July 15, 2016

Last Update Submitted That Met QC Criteria

July 13, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DACL-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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