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Causes and Patterns of Anterior Cruciate Ligament Injuries Among Egyptian Population

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ClinicalTrials.gov Identifier: NCT03773341
Recruitment Status : Not yet recruiting
First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Ali Soliman Ali, Assiut University

Tracking Information
First Submitted Date November 11, 2018
First Posted Date December 12, 2018
Last Update Posted Date December 12, 2018
Estimated Study Start Date January 2019
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 10, 2018)
Patterns of ACL injuries among Egyptian population [ Time Frame: one year ]
Detection of patterns of ACL injuries among 500 Egyptian patient older than 18 years old and younger than 60 years old e.g valgus stress, faulty landing and whether the injury is sport related or not through a validated research questionnaire
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Causes and Patterns of Anterior Cruciate Ligament Injuries Among Egyptian Population
Official Title Causes and Patterns of ACL Injuries Among Egyptian People
Brief Summary The aim of work is to detect the patterns and the causes of ACL injury among Egyptian population and to identify its risk factors. Identify the male to female ratio of injuries in our community. To document the patterns and frequencies of associated injuries
Detailed Description

The ACL (Anterior Cruciate ligament) is one of the most frequently injured ligaments of the knee, with a prevalence estimated to be 1 in 3000 in the US (greater than 120000 cases annually). ACL injury frequently affects young, active individuals. It is also frequently associated with other structural injuries in the Knee joint like meniscal tears and multi-ligamentous injuries. ACL injury leads to increased laxity in the knee, predispose the knee to subsequent injuries and early onset osteoarthritis of the knee.

Sports related trauma is the commonest cause of ACL rupture. Females are reported to have 2 to 10-fold higher risk of injury than males playing the same sport. According to previous studies at Assuit University Hospital the impression was that the ACL injuries are more common in males than females. Additionally, non-sports injuries like motor cycle accidents and domestic injuries are expected to be a major cause of ACL rupture, besides sports injuries, among Egyptian population.

Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Egyptian patients with confirmed ACL injury by clinical and radio logical diagnoses older than 18 years old and younger than 60 years old
Condition ACL Injury
Intervention Other: research questionnaire
Patient personal data History taking clinical knee examination
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: December 10, 2018)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with confirmed ACL injury

Exclusion Criteria:

  • Patients with ACL injury associated with fracture at the same limb
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Ali Soliman Ali, MBBCh 00201097038046 alisuliaman-noman@outlook.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03773341
Other Study ID Numbers ACL injuries
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Ali Soliman Ali, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date December 2018