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Knee Alignment Contributions to Anterior Cruciate Ligament (ACL) Injury

This study has suspended participant recruitment.
(May continue recruiting only if required by journal reviewers)
Sponsor:
Information provided by:
The Orthopaedic Center, Maryland
ClinicalTrials.gov Identifier:
NCT00855023
First received: March 2, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

This study evaluates the the anatomic factors of the knee that may predispose to ACL injury.


Condition
Knee Injuries

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Tibiofemoral Alignment: Contributing Factors to Noncontact Anterior Cruciate Ligament Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Orthopaedic Center, Maryland:

Primary Outcome Measures:
  • Measurement of anatomy of knee [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: November 2007
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • Healthy controls
  • Ages 18-45 years old

Exclusion Criteria:

  • Previous knee injury or surgery
  • Metal implants in body
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855023

Locations
United States, Maryland
Open MRI of Washington
Rockville, Maryland, United States, 20850
Sponsors and Collaborators
The Orthopaedic Center, Maryland
Investigators
Principal Investigator: Barry P Boden, MD The Orthopedic Center
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Barry P. Boden, MD, The Orthopedic Center
ClinicalTrials.gov Identifier: NCT00855023     History of Changes
Other Study ID Numbers: 07-08-229-147
Study First Received: March 2, 2009
Last Updated: March 2, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by The Orthopaedic Center, Maryland:
anterior cruciate ligament
Knee Joint

Additional relevant MeSH terms:
Knee Injuries
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on May 21, 2013