Knee InjuriesNCT00855023
Knee Alignment Contributions to Anterior Cruciate Ligament (ACL) Injury
An observational study of Knee Injuries, run by The Orthopaedic Center, Maryland at 1 site in United States.
Trial summary
This study evaluates the the anatomic factors of the knee that may predispose to ACL injury. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Injuries
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Oct 2010
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: healthy volunteer athletes and excluded those who had any of the following criteria: 1) counter-indications to magnetic resonance imaging (e.g., pregnancy or postsurgical hardware [plates, screws, aneurysm clip, implanted cardiac pacemaker, etc.]); (2) relevant medical problems (e.g., connective tissue problems, paralyzed hemidiaphragm, morbid obesity, claustrophobia, etc.); (3) clinical signs of an impairment or abnormality in the knee (e.g., abnormal range of motion, muscle weakness, or malalignment); (4) injury to the knee that required medical attention; (5) previous surgery on the knee; or (6) current pain in the knee.
Who may be able to join
- Healthy controls
- Ages 18-45 years old
Who cannot join
- Previous knee injury or surgery
- Metal implants in body
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tibiofemoral Alignment: Contributing Factors to Noncontact Anterior Cruciate Ligament Injury
This study evaluates the the anatomic factors of the knee that may predispose to ACL injury.
Read the detailed description
Despite intense study of anterior cruciate ligament injury during the past three decades, the mechanisms of this injury have not been clearly defined. A recent study by the Principle Investigator identified differences in leg alignment when a single leg landing during a sports activity resulted in a torn ACL and when it did not (provocative versus control alignment, respectively).
The purpose of the study is to quantify the tibiofemoral alignment in the lateral compartment of the knee in the provocative landing position and the control landing position. in order to elucidate possible mechanisms of ACL injury Material and Methods: 25 normal controls will be recruited from the greater Washington DC population. Magnetic resonance images in the sagittal plane will be acquired for a single leg of each subject. These images will cover the lateral compartment of the knee and will be acquired with the leg in three positions, one that emulates the injury position, one that exagerrates the injury position, and one that emulates the control landing position. Statistical analysis of the measurements between the provocative, exagerrated provocative, and control positions will then be performed.
These insights could then be applied to improving training focused on reducing the incidences of ACL rupture; improving bracing designs to help athletes most at risk of ACL rupture or those recovering from ACL injury/surgery; and improving ACL replacement surgeries.
- Conditions
- Knee Injuries
- Keywords
- anterior cruciate ligament, Knee Joint
- Medical subject headings
- Knee 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 |
|---|---|---|
| Asymptomatic Volunteers | healthy volunteer athletes and excluded those who had any of the following criteria: 1) counter-indications to magnetic resonance imaging (e.g., pregnancy or postsurgical hardware [plates, screws, aneurysm clip, implanted cardiac pacemaker, etc.]); (2) relevant medical problems (e.g., connective tissue problems, paralyzed hemidiaphragm, morbid obesity, claustrophobia, etc.); (3) clinical signs of an impairment or abnormality in the knee (e.g., abnormal range of motion, muscle weakness, or malalignment); (4) injury to the knee that required medical attention; (5) previous surgery on the knee; or (6) current pain in the knee. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of anatomy of knee
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2009 (estimated)
- Study startNov 2007
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Orthopaedic Center, Maryland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barry P. Boden, MD, The Orthopaedic Center, Maryland
- Investigators
- Barry P Boden, MD, Principal investigator, The Orthopedic Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855023
- Sponsor's protocol ID
- 07-08-229-147
- Status last verified
- Mar 2009
- First submitted
- 2 Mar 2009
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Boden BP, Torg JS, Knowles SB, Hewett TE. Video analysis of anterior cruciate ligament injury: abnormalities in hip and ankle kinematics. Am J Sports Med. 2009 Feb;37(2):252-9. doi: 10.1177/0363546508328107.
PubMed 19182110Boden BP, Breit I, Sheehan FT. Tibiofemoral alignment: contributing factors to noncontact anterior cruciate ligament injury. J Bone Joint Surg Am. 2009 Oct;91(10):2381-9. doi: 10.2106/JBJS.H.01721.
PubMed 19797573
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tibiofemoral Alignment: Contributing Factors to Noncontact Anterior Cruciate Ligament Injury
- ClinicalTrials.gov ID
- NCT00855023
- Acronym / sponsor ID
- 07-08-229-147
- Conditions
- Knee Injuries
- Keywords
- anterior cruciate ligament, Knee Joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- The Orthopaedic Center, MarylandUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 3 Mar 2009 (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.
This study evaluates the the anatomic factors of the knee that may predispose to ACL injury.
Detailed description
Despite intense study of anterior cruciate ligament injury during the past three decades, the mechanisms of this injury have not been clearly defined. A recent study by the Principle Investigator identified differences in leg alignment when a single leg landing during a sports activity resulted in a torn ACL and when it did not (provocative versus control alignment, respectively).
The purpose of the study is to quantify the tibiofemoral alignment in the lateral compartment of the knee in the provocative landing position and the control landing position. in order to elucidate possible mechanisms of ACL injury Material and Methods: 25 normal controls will be recruited from the greater Washington DC population. Magnetic resonance images in the sagittal plane will be acquired for a single leg of each subject. These images will cover the lateral compartment of the knee and will be acquired with the leg in three positions, one that emulates the injury position, one that exagerrates the injury position, and one that emulates the control landing position. Statistical analysis of the measurements between the provocative, exagerrated provocative, and control positions will then be performed.
These insights could then be applied to improving training focused on reducing the incidences of ACL rupture; improving bracing designs to help athletes most at risk of ACL rupture or those recovering from ACL injury/surgery; and improving ACL replacement surgeries.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic Volunteers | – | –healthy volunteer athletes and excluded those who had any of the following criteria: 1) counter-indications to magnetic resonance imaging (e.g., pregnancy or postsurgical hardware [plates, screws, aneurysm clip, implanted cardiac pacemaker, etc.]); (2) relevant medical problems (e.g., connective tissue problems, paralyzed hemidiaphragm, morbid obesity, claustrophobia, etc.); (3) clinical signs of an impairment or abnormality in the knee (e.g., abnormal range of motion, muscle weakness, or malalignment); (4) injury to the knee that required medical attention; (5) previous surgery on the knee; or (6) current pain in the knee. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy volunteer athletes and excluded those who had any of the following criteria: 1) counter-indications to magnetic resonance imaging (e.g., pregnancy or postsurgical hardware [plates, screws, aneurysm clip, implanted cardiac pacemaker, etc.]); (2) relevant medical problems (e.g., connective tissue problems, paralyzed hemidiaphragm, morbid obesity, claustrophobia, etc.); (3) clinical signs of an impairment or abnormality in the knee (e.g., abnormal range of motion, muscle weakness, or malalignment); (4) injury to the knee that required medical attention; (5) previous surgery on the knee; or (6) current pain in the knee.
Key inclusion criteria (2 listed)
- Healthy controls
- Ages 18-45 years old
Key exclusion criteria (2 listed)
- Previous knee injury or surgery
- Metal implants in body
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
Measurement of anatomy of knee
Time frame: 1 hour
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 18 Mar 2020.
- Background: PubMed 19182110Boden BP, Torg JS, Knowles SB, Hewett TE. Video analysis of anterior cruciate ligament injury: abnormalities in hip and ankle kinematics. Am J Sports Med. 2009 Feb;37(2):252-9. doi: 10.1177/0363546508328107.
- Derived from this study: PubMed 19797573Boden BP, Breit I, Sheehan FT. Tibiofemoral alignment: contributing factors to noncontact anterior cruciate ligament injury. J Bone Joint Surg Am. 2009 Oct;91(10):2381-9. doi: 10.2106/JBJS.H.01721.
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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.
Barry P Boden, MD principal investigator
The Orthopedic Center
1 site 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, run by The Orthopaedic Center, Maryland at 1 site 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 2 inclusion and 2 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 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does the primary outcome measure?
Measurement of anatomy of knee (time frame: 1 hour). 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 NCT00855023, which also lists 2 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 18 Mar 2020.