Clinical Trial on Knee Injuries - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Knee Injuries

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 Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Maryland
  - Rockville, Maryland, United States, 20850
    - Open MRI of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

Healthy controls
Ages 18-45 years old

Exclusion Criteria:

Previous knee injury or surgery
Metal implants in body

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

Group / Cohort

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 the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measurement of anatomy of knee Time Frame: 1 hour	1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Orthopaedic Center, Maryland

Investigators

Principal Investigator: Barry P Boden, MD, The Orthopedic Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

March 2, 2009

First Submitted That Met QC Criteria