Comparison of Early Versus Delay Reconstruction in Anterior Cruciate Ligament Tearing

NCT ID: NCT01580722

Last Updated: 2012-04-19

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-04-30

Brief Summary

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The purpose of this study is to determine which surgical method is better for anterior cruciate ligament teas in outcomes.

Detailed Description

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The anterior cruciate ligament (ACL) is one of the most commonly injured ligaments of the knee. This study was conducted to determine whether the outcome of treatment is superior in early surgical reconstruction compared with optional delay reconstruction.

Conditions

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Anterior Cruciate Ligament Tear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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early

patients underwent \< 8 weeks reconstruction after injury

Group Type OTHER

early reconstruction

Intervention Type PROCEDURE

patients underwent \< 8 weeks reconstruction after injury

delay

patients underwent \> 8 weeks reconstruction after injury

Group Type OTHER

delay reconstruction

Intervention Type PROCEDURE

patients underwent \> 8 weeks reconstruction after injury

Interventions

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early reconstruction

patients underwent \< 8 weeks reconstruction after injury

Intervention Type PROCEDURE

delay reconstruction

patients underwent \> 8 weeks reconstruction after injury

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

a. patients with confirmed anterior cruciate ligament tearing

Exclusion Criteria

One of the following associated injuries to the index knee as visualized on MRI and/or arthroscopy:

1. An unstable longitudinal meniscus tear that requires repair and where the following postoperative treatment (i.e. bracing and limited ROM) interferes with the rehabilitation protocol
2. Bi-compartmental extensive meniscus resections
3. A cartilage injury representing a full thickness loss down to bone
4. A total rupture of MCL/LCL as visualized on MRI
Minimum Eligible Age

18 Years

Maximum Eligible Age

36 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Hamidreza Shemshaki

principle

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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hamidreza shemshaki, MD

Role: STUDY_CHAIR

MD,research comittee

Locations

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Al-zahra university hospital

Isfahan, Isfahan, Iran

Site Status

Countries

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Iran

Other Identifiers

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ASD-1213-100

Identifier Type: -

Identifier Source: org_study_id

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