Study of Single And Double Bundle Anterior Cruciate Ligament (ACL) Graft Cross-sectional Dimensions

July 14, 2016 updated by: Jia-kuo yu, Peking University Third Hospital

Study of Single And Double Bundle ACL Graft Cross-sectional Dimensions Compared With Native ACL

To study the difference between single and double bundle ACL graft cross-sectional dimensions compared with native ACL using postoperative 3-D MRI.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The investigators divide 100 patients with ACL rupture into 2 groups. Group A undergo single bundle anterior cruciate ligament reconstruction (ACLR). Group B undergo double bundle ACL reconstruction. At 3-6 weeks post operation, all the patients undergo 3-D MRI examination of both knees. The investigators reconstruct 3-D models of reconstructed ACL and native ACL, and compare the difference between single and double bundle graft.

Study Type

Interventional

Enrollment (Anticipated)

100

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

10 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ACL rupture patients aged between 10 to 50 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 inflammatory 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
Experimental: single bundle ACLR
patients undergo single bundle ACL reconstruction
Procedure: single bundle ACL reconstruction
anterior cruciate ligament reconstruction using single bundle technique
Active Comparator: double bundle ACLR
patients undergo double bundle ACL reconstruction
Procedure: double bundle ACL reconstruction
anterior cruciate ligament reconstruction using double bundle technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cross-sectional area of the reconstructed ACL
Time Frame: 3-6 weeks
3-6 weeks
long to short axis ratio of the cross-sectional area of the reconstructed ACL
Time Frame: 3-6 weeks
3-6 weeks
long axis of the cross-sectional area of the reconstructed ACL
Time Frame: 3-6 weeks
3-6 weeks
short axis of the cross-sectional area of the reconstructed ACL
Time Frame: 3-6 weeks
3-6 weeks

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, 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, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

July 13, 2016

First Submitted That Met QC Criteria

July 13, 2016

First Posted (Estimate)

July 15, 2016

Study Record Updates

Last Update Posted (Estimate)

July 18, 2016

Last Update Submitted That Met QC Criteria

July 14, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACLMRI-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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