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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
  Purpose

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


Condition Intervention Phase
Anterior Cruciate Ligament Tear
 Procedure: early reconstruction
Procedure: delay reconstruction
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Surgical Methods for Anterior Cruciate Ligament Tearing

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ) .


Enrollment: 202
Study Start Date: March 2012
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
early
patients underwent < 8 weeks reconstruction after injury
 Procedure: early reconstruction
patients underwent < 8 weeks reconstruction after injury
delay
patients underwent > 8 weeks reconstruction after injury
 Procedure: delay reconstruction
patients underwent > 8 weeks reconstruction after injury

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.

  Eligibility

Ages Eligible for Study:   18 Years to 36 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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:

  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01580722

Locations
Iran, Islamic Republic of
Al-zahra university hospital
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
Study Chair: hamidreza shemshaki, MD MD,research comittee
  More Information

Additional Information:
Isfahan university of medical science  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Hamidreza Shemshaki, principle, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01580722     History of Changes
Other Study ID Numbers: ASD-1213-100
Study First Received: April 18, 2012
Last Updated: April 18, 2012
Health Authority: Iran: Ministry of Health

Keywords provided by Isfahan University of Medical Sciences:
Anterior Cruciate Ligament,Early,Delay,Reconstruction

ClinicalTrials.gov processed this record on May 23, 2013