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

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-08-31

Brief Summary

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

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Detailed Description

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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.

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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single bundle ACLR

patients undergo single bundle ACL reconstruction

Group Type EXPERIMENTAL

single bundle ACL reconstruction

Intervention Type PROCEDURE

anterior cruciate ligament reconstruction using single bundle technique

double bundle ACLR

patients undergo double bundle ACL reconstruction

Group Type ACTIVE_COMPARATOR

double bundle ACL reconstruction

Intervention Type PROCEDURE

anterior cruciate ligament reconstruction using double bundle technique

Interventions

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single bundle ACL reconstruction

anterior cruciate ligament reconstruction using single bundle technique

Intervention Type PROCEDURE

double bundle ACL 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 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

Minimum Eligible Age

10 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No