Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
750 participants
OBSERVATIONAL
2003-03-05
Brief Summary
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Healthy normal volunteers must be age 5 to unlimited, with or without joint impairment, may be eligible for this study. Volunteers with joint impairment may not have serious injury to the joint being studied, previous surgery on the joint being studied, or extreme pain at the joint being studied.
MRI uses a strong magnet and radio waves to create images of the inside of the body. The subject lies on a long narrow couch inside a metal cylinder (the scanner) for up to 3 hours while the scanner gathers data. Earplugs are worn to muffle loud noises caused by electrical switching of radiofrequency circuits used in the scanning process. A special pad or tube may be placed over or around the region being scanned to improve the quality of the data. The subject will be asked to repeatedly move a specific joint, such as the knee, for brief periods, usually less than 5 minutes. The subject can communicate via intercom with the person performing the study at all times during the procedure, and may request to stop the study at any time.
Detailed Description
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The principal investigator has previously developed and tested the primary component in the VFA package, cine-phase contrast and fast-phase contrast (fast-PC) MR imaging, demonstrating both to be highly accurate and precise in the measurement of normal 3D knee joint kinematics and biceps femoris strain. Additional investigators have previously developed techniques for imaging musculoskeletal structures using ultrasonography, demonstrating these techniques to be, likewise, highly accurate and precise in the measurement of biomechanical properties of the soft tissues surrounding the knee and the tendons of the quadriceps femoris. Under this protocol we propose to develop additional numerical reconstruction, image analysis, and display methods and test the applicability of fast-PC MR and ultrasound imaging to the study of various normal and impaired joints (e.g., ankle, wrist, and knee). This development process will require data from human volunteers obtained from both static and dynamic MR and ultrasound images.
This development process will require data from human subjects obtained from both static and dynamic MR and ultrasound images. This development is being guided by our philosophy that impaired joint function likely occurs due to abnormal bone shape, abnormal musculoskeletal movements and forces, or both abnormal bone shape and musculoskeletal movements and forces. Thus, our long-term vision is to non-invasively quantify the in vivo 3D joint kinematics, bone shapes and tissue loads for both the impaired and normal volunteer populations, translate the methods and findings into interventional research and ultimately into common clinical practice.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1/Healthy Controls
Subjects 5 years old and up with musculoskeletal impairment, pathology, or variant.
No interventions assigned to this group
2/Healthy Volunteers
Subjects 5 years old and up without musculoskeletal impairment, pathology, or variant.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Must be between the ages of 5-95 years.
* Minors \< 18 years of age, they must be capable of providing assent (verbal or written) with parental or legal guardian permissions obtained.
* Adults 18 \>= years of age, they must be able to provide informed consent.
* Have the presence of a bone, muscle, soft tissue, connective tissue injury, impairment or related muscular skeletal system pathology.
* Ability to have an MRI Scan.
Healthy Volunteer Participants
* Must be between the ages of 5-95 years.
* Minors \< 18 years of age, they must be capable of providing assent (verbal or written) with parental or legal guardian permissions obtained.
* Adults 18 \>= years of age, they must be able to provide informed consent.
* Ability to have an MRI Scan.
Exclusion Criteria
-For the MR imaging portion of this study, all participants must complete the NIH Diagnostic Radiology screening questionnaire. If any potential contraindication is found, either the volunteer s doctor (with knowledge of the potential contraindication) or the radiology department at the NIH will be contacted to determine if the potential contraindication would exclude them from the specific MR scans being proposed.
Healthy Volunteer Participants
* Any relevant medical problems
* Clinical signs of an impairment in the joint/limb being studied.
* Any serious injury to the joint/limb being studied, previous surgery on the joint/limb being studied or extreme pain at the joint/limb being studied.
* Neurologic Pathology affecting the muscular skeletal system
* For the MR imaging portion of this study, all participants must complete the NIH Diagnostic Radiology screening questionnaire. If any potential contraindication is found, either the volunteer s doctor (with knowledge of the potential contraindication) or the radiology department at the NIH will be contacted to determine if the potential contraindication would exclude them from the specific MR scans being proposed.
5 Years
95 Years
ALL
Yes
Sponsors
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National Institutes of Health Clinical Center (CC)
NIH
Responsible Party
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Principal Investigators
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Frances T Gavelli, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Institutes of Health Clinical Center (CC)
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
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Central Contacts
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Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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03-CC-0060
Identifier Type: -
Identifier Source: secondary_id
030060
Identifier Type: -
Identifier Source: org_study_id