Comparison of Early Versus Delay Reconstruction in Anterior Cruciate Ligament Tearing

April 18, 2012 updated by: Hamidreza Shemshaki, Isfahan University of Medical Sciences

Study of Surgical Methods for Anterior Cruciate Ligament Tearing

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

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

18 years to 36 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: early
patients underwent < 8 weeks reconstruction after injury
Procedure: early reconstruction
patients underwent < 8 weeks reconstruction after injury
Other: delay
patients underwent > 8 weeks reconstruction after injury
Procedure: delay reconstruction
patients underwent > 8 weeks reconstruction after injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life
Time Frame: at 6 months post-operatively
SF-36 questionnaire consists of 36 questions (two main components: physical and mental), each of which was assigned a score ranging from 0 to 100.
at 6 months post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tegner activity score
Time Frame: at 6 months post-operatively
The Tegner Activity Scale depicts the level of sporting activity and allows us to compare and document the preinjury activity level with the present activity level. This numeric score ranging from 1 to 10 where 1 is the least strenuous activity for the knee and 10 is the hardest.
at 6 months post-operatively
Knee injury and Osteoarthritis Outcome Score
Time Frame: at 6 months post-operatively
The Knee injury and Osteoarthritis Outcome Score is the extended form of The Western Ontario and McMaster Universities Arthritis Index (WOMAC) with 42 - items in 5 subscales consisting : pain ( 9 items ) , other symptoms ( 7 items ) , activities of daily living ( 17 items ) , sports and recreational function ( sport / rec ) ( 5 items ) , and knee - related quality of life ( QOL ) ( 4 items ) .
at 6 months post-operatively

Collaborators and Investigators

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

Sponsor

Isfahan University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

March 1, 2012

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

April 18, 2012

First Submitted That Met QC Criteria

April 18, 2012

First Posted (Estimate)

April 19, 2012

Study Record Updates

Last Update Posted (Estimate)

April 19, 2012

Last Update Submitted That Met QC Criteria

April 18, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASD-1213-100

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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