Knee InjuriesNCT00124319
Risk Factors for Anterior Cruciate Ligament (ACL) Injury
An observational study of Knee Injuries and Athletic Injuries, run by Steve Marshall at 3 sites in United States.
Trial summary
The anterior cruciate ligament (ACL) is located inside the knee joint and provides stability to the knee. ACL injuries occur more frequently in women than men; the reason for this is unknown. The purpose of this study is to determine gender-specific anatomical, hormonal, and demographic risk factors for ACL injury. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Injuries, Athletic Injuries
- How many people
- 4,800 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2005to Mar 2011
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Incoming cadets at the U.S. Naval, Air Force, or Military Academies
Who may be able to join
- Incoming cadet at the U.S. Naval, Air Force, or Military Academies
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
U.S. Naval Academy
Annapolis, Maryland, 21402-5000
U.S. Air Force Academy
Colorado Springs, Colorado, 80840
U.S. Military Academy
West Point, New York, 10996
About this study
Official title: Epidemiology of Jump-Landing Movements and ACL Injury
The anterior cruciate ligament (ACL) is located inside the knee joint and provides stability to the knee. ACL injuries occur more frequently in women than men; the reason for this is unknown. The purpose of this study is to determine gender-specific anatomical, hormonal, and demographic risk factors for ACL injury. This observational cohort study will only enroll incoming cadets at the U.S. Naval, Air Force, or Military Academies.
Study hypothesis: Human movement factors, including key kinetics and kinematics of the knee during a jump-landing task, are associated with the rate of ACL injury.
Read the detailed description
The ACL stabilizes the knee joint by preventing the shinbone (tibia) from sliding forward beneath the thighbone (femur). A hard twist or excessive pressure on the ACL can tear or rupture the ligament, resulting in high levels of short-term disability and extensive rehabilitation. Previous data indicate that women who participate in sports or who are otherwise physically active have higher rates of ACL injury than men; the reason for this is unknown. There are four groups of potential risk factors for ACL injury: environmental, anatomical, hormonal, and biomechanical or neuromuscular. In particular, poor technique when landing from a jump (also known as jump-landing) is proposed as a specific neuromuscular risk factor of interest in this study. This study will determine gender-specific anatomical, hormonal, and demographic risk factors for ACL injury, as well as quantify gender-specific differences in jump-landing technique and other neuromuscular risk factors.
This observational cohort study will enroll 4,800 cadets at the three large U.S. military academies; approximately 50% of those enrolled will be women. Only incoming cadets at the U.S. Naval, Air Force, or Military Academies will be able to participate. Each study participant will undergo a baseline assessment that will include measurement of neuromuscular risk factors using motion analysis, strength testing, and standardized assessment of poor jump-landing technique using the Landing Error Score System (LESS). All participants will be followed for up to 4 years. ACL injuries will be prospectively identified; an injury questionnaire is administered to participants who sustain an ACL injury while they are cadets. Otherwise, there is no further contact.
- Conditions
- Knee Injuries, Athletic Injuries
- Keywords
- Biomechanics, Neuromuscular, Lower limb, Injury, ACL, Anterior Cruciate Ligament injury
- Medical subject headings
- Knee Injuries, Athletic Injuries, Wounds and Injuries, Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Incoming cadets at the U.S. Naval, Air Force, or Military Academies |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2005 (estimated)
- Study startJun 2005
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steve Marshall
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), United States Department of Defense
- Responsible party
- Sponsor-investigator, Steve Marshall, University of North Carolina, Chapel Hill
- Investigators
- Stephen W. Marshall, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00124319
- Sponsor's protocol ID
- R01AR050461
- Other IDs
- R01AR050461, R01AR050461-01A1
- Status last verified
- May 2009
- First submitted
- 25 Jul 2005
- Last updated
- 5 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Jump-Landing Movements and ACL Injury
- ClinicalTrials.gov ID
- NCT00124319
- Acronym / sponsor ID
- R01AR050461
- Conditions
- Knee Injuries, Athletic Injuries
- Keywords
- Biomechanics, Neuromuscular, Lower limb, Injury, ACL, Anterior Cruciate Ligament injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,800 participants (estimated)
- Lead sponsor
- Steve MarshallUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), United States Department of Defense
- Study start
- Jun 2005
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 27 Jul 2005 (estimated)
- 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 anterior cruciate ligament (ACL) is located inside the knee joint and provides stability to the knee. ACL injuries occur more frequently in women than men; the reason for this is unknown. The purpose of this study is to determine gender-specific anatomical, hormonal, and demographic risk factors for ACL injury. This observational cohort study will only enroll incoming cadets at the U.S. Naval, Air Force, or Military Academies.
Study hypothesis: Human movement factors, including key kinetics and kinematics of the knee during a jump-landing task, are associated with the rate of ACL injury.
Detailed description
The ACL stabilizes the knee joint by preventing the shinbone (tibia) from sliding forward beneath the thighbone (femur). A hard twist or excessive pressure on the ACL can tear or rupture the ligament, resulting in high levels of short-term disability and extensive rehabilitation. Previous data indicate that women who participate in sports or who are otherwise physically active have higher rates of ACL injury than men; the reason for this is unknown. There are four groups of potential risk factors for ACL injury: environmental, anatomical, hormonal, and biomechanical or neuromuscular. In particular, poor technique when landing from a jump (also known as jump-landing) is proposed as a specific neuromuscular risk factor of interest in this study. This study will determine gender-specific anatomical, hormonal, and demographic risk factors for ACL injury, as well as quantify gender-specific differences in jump-landing technique and other neuromuscular risk factors.
This observational cohort study will enroll 4,800 cadets at the three large U.S. military academies; approximately 50% of those enrolled will be women. Only incoming cadets at the U.S. Naval, Air Force, or Military Academies will be able to participate. Each study participant will undergo a baseline assessment that will include measurement of neuromuscular risk factors using motion analysis, strength testing, and standardized assessment of poor jump-landing technique using the Landing Error Score System (LESS). All participants will be followed for up to 4 years. ACL injuries will be prospectively identified; an injury questionnaire is administered to participants who sustain an ACL injury while they are cadets. Otherwise, there is no further contact.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Incoming cadets at the U.S. Naval, Air Force, or Military Academies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Incoming cadets at the U.S. Naval, Air Force, or Military Academies
Key inclusion criteria (1 listed)
- Incoming cadet at the U.S. Naval, Air Force, or Military Academies
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2011.
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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.
Stephen W. Marshall, PhD principal investigator
University of North Carolina, Chapel Hill
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Injuries and Athletic Injuries, run by Steve Marshall at 3 sites in United States.
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 0 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: finished, as of the sponsor's last update on 5 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 5 Oct 2011.