Back to resultsComparison of Early Versus Delay Reconstruction in Anterior Cruciate Ligament Tearing
Primary Purpose
Anterior Cruciate Ligament Tear
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
early reconstruction
delay reconstruction
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Tear focused on measuring Anterior Cruciate Ligament,Early,Delay,Reconstruction
Eligibility Criteria
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
Sites / Locations
- Al-zahra university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
early
delay
Arm Description
patients underwent < 8 weeks reconstruction after injury
patients underwent > 8 weeks reconstruction after injury
Outcomes
Primary Outcome Measures
quality of life
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.
Secondary Outcome Measures
Tegner activity score
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
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 ) .
Full Information
NCT ID
NCT01580722
First Posted
April 18, 2012
Last Updated
April 18, 2012
Sponsor
Isfahan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01580722
Brief Title
Comparison of Early Versus Delay Reconstruction in Anterior Cruciate Ligament Tearing
Official Title
Study of Surgical Methods for Anterior Cruciate Ligament Tearing
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Tear
Keywords
Anterior Cruciate Ligament,Early,Delay,Reconstruction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
202 (Actual)
8. Arms, Groups, and Interventions
Arm Title
early
Arm Type
Other
Arm Description
patients underwent < 8 weeks reconstruction after injury
Arm Title
delay
Arm Type
Other
Arm Description
patients underwent > 8 weeks reconstruction after injury
Intervention Type
Procedure
Intervention Name(s)
early reconstruction
Intervention Description
patients underwent < 8 weeks reconstruction after injury
Intervention Type
Procedure
Intervention Name(s)
delay reconstruction
Intervention Description
patients underwent > 8 weeks reconstruction after injury
Primary Outcome Measure Information:
Title
quality of life
Description
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.
Time Frame
at 6 months post-operatively
Secondary Outcome Measure Information:
Title
Tegner activity score
Description
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.
Time Frame
at 6 months post-operatively
Title
Knee injury and Osteoarthritis Outcome Score
Description
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 ) .
Time Frame
at 6 months post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hamidreza shemshaki, MD
Organizational Affiliation
MD,research comittee
Official's Role
Study Chair
Facility Information:
Facility Name
Al-zahra university hospital
City
Isfahan
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Links:
URL
http://www.mui.ac.ir
Description
Isfahan university of medical science
Learn more about this trial
Comparison of Early Versus Delay Reconstruction in Anterior Cruciate Ligament Tearing
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