Comparison of Early Versus Delay Reconstruction in Anterior Cruciate Ligament Tearing

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Hamidreza Shemshaki, Isfahan University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT01580722

First received: April 18, 2012

Last updated: NA

Last verified: April 2012

History: No changes posted

Tracking Information

First Received Date ^ICMJE

April 18, 2012

Last Updated Date

April 18, 2012

Start Date ^ICMJE

March 2012

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

quality of life [ Time Frame: at 6 months post-operatively ] [ Designated as safety issue: Yes ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Tegner activity score [ Time Frame: at 6 months post-operatively ] [ Designated as safety issue: Yes ]
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.
Knee injury and Osteoarthritis Outcome Score [ Time Frame: at 6 months post-operatively ] [ Designated as safety issue: Yes ]
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 ) .

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparison of Early Versus Delay Reconstruction in Anterior Cruciate Ligament Tearing

Official Title ^ICMJE

Study of Surgical Methods for Anterior Cruciate Ligament Tearing

Brief Summary

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

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 ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Anterior Cruciate Ligament Tear

Intervention ^ICMJE

Procedure: early reconstruction
patients underwent < 8 weeks reconstruction after injury
Procedure: delay reconstruction
patients underwent > 8 weeks reconstruction after injury

Study Arm (s)

early
patients underwent < 8 weeks reconstruction after injury

Intervention: Procedure: early reconstruction
delay
patients underwent > 8 weeks reconstruction after injury

Intervention: Procedure: delay reconstruction

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

202

Completion Date

April 2012

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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:

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
Bi-compartmental extensive meniscus resections
A cartilage injury representing a full thickness loss down to bone
A total rupture of MCL/LCL as visualized on MRI

Gender

Both

Ages

18 Years to 36 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Iran, Islamic Republic of

Administrative Information

NCT Number ^ICMJE

NCT01580722

Other Study ID Numbers ^ICMJE

ASD-1213-100

Has Data Monitoring Committee

Yes

Responsible Party

Hamidreza Shemshaki, Isfahan University of Medical Sciences

Study Sponsor ^ICMJE

Isfahan University of Medical Sciences

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

hamidreza shemshaki, MD

MD,research comittee

Information Provided By

Isfahan University of Medical Sciences

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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