ACL InjuryNCT03773341
Causes and Patterns of Anterior Cruciate Ligament Injuries Among Egyptian Population
An observational study of ACL Injury, run by Assiut University.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- ACL Injury
- What is being tested?
- research questionnaire
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- Patients with confirmed ACL injury
Who cannot join
- Patients with ACL injury associated with fracture at the same limb
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Causes and Patterns of ACL Injuries Among Egyptian People
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
Read the 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.
- Conditions
- ACL Injury
- Being tested
- research questionnaire
- Keywords
- ACL injury, non sport causes, Egyptians
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
research questionnaireOther
Patient personal data History taking clinical knee examination
What is being measured
The primary outcome is the main question the study is designed to answer.
Patterns of ACL injuries among Egyptian population
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study startJan 2019 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Soliman Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773341
- Sponsor's protocol ID
- ACL injuries
- Status last verified
- Dec 2018
- First submitted
- 11 Nov 2018
- Last updated
- 12 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Levine JW, Kiapour AM, Quatman CE, Wordeman SC, Goel VK, Hewett TE, Demetropoulos CK. Clinically relevant injury patterns after an anterior cruciate ligament injury provide insight into injury mechanisms. Am J Sports Med. 2013 Feb;41(2):385-95. doi: 10.1177/0363546512465167. Epub 2012 Nov 9.
PubMed 23144366Arendt E, Dick R. Knee injury patterns among men and women in collegiate basketball and soccer. NCAA data and review of literature. Am J Sports Med. 1995 Nov-Dec;23(6):694-701. doi: 10.1177/036354659502300611.
PubMed 8600737Anderson AF, Dome DC, Gautam S, Awh MH, Rennirt GW. Correlation of anthropometric measurements, strength, anterior cruciate ligament size, and intercondylar notch characteristics to sex differences in anterior cruciate ligament tear rates. Am J Sports Med. 2001 Jan-Feb;29(1):58-66. doi: 10.1177/03635465010290011501.
PubMed 11206258
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Causes and Patterns of ACL Injuries Among Egyptian People
- ClinicalTrials.gov ID
- NCT03773341
- Acronym / sponsor ID
- ACL injuries
- Conditions
- ACL Injury
- Keywords
- ACL injury, non sport causes, Egyptians
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 12 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- Patients with confirmed ACL injury
Key exclusion criteria (1 listed)
- Patients with ACL injury associated with fracture at the same limb
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| research questionnairePatient personal data History taking clinical knee examination | Other | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
- Background: PubMed 23144366Levine JW, Kiapour AM, Quatman CE, Wordeman SC, Goel VK, Hewett TE, Demetropoulos CK. Clinically relevant injury patterns after an anterior cruciate ligament injury provide insight into injury mechanisms. Am J Sports Med. 2013 Feb;41(2):385-95. doi: 10.1177/0363546512465167. Epub 2012 Nov 9.
- Background: PubMed 8600737Arendt E, Dick R. Knee injury patterns among men and women in collegiate basketball and soccer. NCAA data and review of literature. Am J Sports Med. 1995 Nov-Dec;23(6):694-701. doi: 10.1177/036354659502300611.
- Background: PubMed 11206258Anderson AF, Dome DC, Gautam S, Awh MH, Rennirt GW. Correlation of anthropometric measurements, strength, anterior cruciate ligament size, and intercondylar notch characteristics to sex differences in anterior cruciate ligament tear rates. Am J Sports Med. 2001 Jan-Feb;29(1):58-66. doi: 10.1177/03635465010290011501.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of ACL Injury, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Soliman Ali, MBBCh (00201097038046, alisuliaman-noman@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patterns of ACL injuries among Egyptian population (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03773341, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2018.