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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

April 18, 2012
April 18, 2012
March 2012
March 2012   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
  • 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 ) .
Same as current
Not Provided
Not Provided
 
Comparison of Early Versus Delay Reconstruction in Anterior Cruciate Ligament Tearing
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Anterior Cruciate Ligament Tear
  • Procedure: early reconstruction
    patients underwent < 8 weeks reconstruction after injury
  • Procedure: delay reconstruction
    patients underwent > 8 weeks reconstruction after injury
  • early
    patients underwent < 8 weeks reconstruction after injury
    Intervention: Procedure: early reconstruction
  • delay
    patients underwent > 8 weeks reconstruction after injury
    Intervention: Procedure: delay reconstruction
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
202
April 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 36 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01580722
ASD-1213-100
Yes
Hamidreza Shemshaki, Isfahan University of Medical Sciences
Isfahan University of Medical Sciences
Not Provided
Study Chair: hamidreza shemshaki, MD MD,research comittee
Isfahan University of Medical Sciences
April 2012

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