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MRI Study of Musculoskeletal Function

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ClinicalTrials.gov Identifier: NCT00051857
Recruitment Status : Recruiting
First Posted : January 17, 2003
Last Update Posted : December 28, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

Brief Summary:

This study will use magnetic resonance imaging (MRI) and ultrasound images to study how muscles, tendons, and bones work together to cause motion. The procedure is one of several tools being developed to characterize normal and impaired musculoskeletal function, with the goal of developing improved methods of diagnosis and treatment of movement disorders.

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.

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Condition or disease
Abnormalities Imaging Patellofemoral Pain Syndrome

Detailed Description:

The overall goal of this technology development initiative is to greatly advance the clinical diagnosis and treatment of musculoskeletal impairments as they relate to joint function. The primary focus of this protocol is to initially develop and ultimately validate a combined set of tools (virtual functional anatomy - VFA) that will enable the accurate and precise measurement, analysis and visualization of three-dimensional (3D) static and dynamic musculoskeletal anatomy (i.e., bone shape, skeletal kinematics, tendon and ligament strain, muscle force, and joint space) from imaging data. We plan to merge and extend our existing MR imaging and analysis capabilities with ultrasound imaging and analysis for the development and implementation of a highly accurate, imaging-based measurement and analysis technique for the non-invasive quantification of complete joint anatomy and tissue dynamics during functional movements. In short, we plan to develop a method for creating 3D digital images of loaded and moving joint tissues (bone, cartilage, and connective tissues) that reveal joint contact patterns and tissue loads. In conjunction with building this tool, we will evaluate the variability of bone shape across individuals, the sensitivity of defined joint posture (translation and rotation of one bone relative to another) to osteo-based coordinate system definition, and the ability to ultimately use these tools to document and evaluate the function of normal and impaired joint structures (e.g., ACL rupture, patella tracking syndrome ) under simulated conditions experienced during activities of daily living.

The principal investigator has previously developed and tested the primary component in the VFA package, cine-phase contrast and fast-phase contrast (fast-PC) MRI, 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 MRI and ultrasound 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 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 healthy impaired and normal volunteer populations, translate the methods and findings into interventional research and ultimately into common clinical practice.

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Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Virtual Functional Anatomy (VFA)
Actual Study Start Date : March 5, 2003

Group/Cohort
1/Healthy Controls
Subjects 5 years old and up with musculoskeletal impairment, pathology, or variant.
2/Healthy Volunteers
Subjects 5 years old and up without musculoskeletal impairment, pathology, or variant.



Primary Outcome Measures :
  1. Dynamic MRI measures of in vivo tissue velocity, bone and muscle, during dynamic tasks of knee flexion/extension [ Time Frame: End of study ]
    MRI techniques to non-invasively measure the 3D in vivo musculoskeletal kinematics, bone shapes, and muscle-tendon lengths in the joints of normal volunteers and healthy volunteers with specific joint impairments.


Secondary Outcome Measures :
  1. B-mode ultra-sound of muscles and bones that compose the knee joint [ Time Frame: End of Study ]
    Ultrasound techniques to non- invasively measure the 3D in vivo musculoskeletal kinematics, bone shapes, and muscle-tendon lengths in the joints of normal volunteers and healthy volunteers with specific joint impairments.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 95 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Participants will be primarily from the greater Washington DC area.
Criteria
  • INCLUSION CRITERIA:
  • All individuals must be between ages of 5 to 95. For subjects under 18 years of age, they must be capable of giving assent with a parent or legal guardian providing parental/guardian permission
  • For subjects ages 18 and above, they must be able to provide informed consent. Subjects will either be healthy controls or affected individuals with a specific musculoskeletal impairment, pathology, or variant.

EXCLUSION CRITERIA - HEALTHY VOLUNTEERS:

  • Any relevant medical problems (connective tissue problems, active arthritis, etc.)
  • Any clinical signs of an impairment in the joint being studied, such as mechanical joint abnormalities including abnormal range of motion, muscle weakness, malalignment.
  • Any serious injury to the joint being studied, previous surgery on the joint being studied or extreme pain at the joint being studied.

EXCLUSION CRITERIA - ALL VOLUNTEERS:

All potentials volunteers for the MR portion of this study 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 you from the specific MR scans being proposed. Volunteers will be excluded if it is deemed that they have a condition, which would preclude them from participating in an MRI study (e.g. paralyzed hemidiaphragm, morbid obesity, claustrophobia).

Lastly, females who are pregnant will be excluded from participating in this study in order to prevent any possible damage to the fetus.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00051857


Contacts
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Contact: Frances Gavelli, Ph.D. (301) 451-7585 gavellif@cc.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Investigators
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Principal Investigator: Frances Gavelli, Ph.D. National Institutes of Health Clinical Center (CC)
Additional Information:
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Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00051857    
Other Study ID Numbers: 030060
03-CC-0060
First Posted: January 17, 2003    Key Record Dates
Last Update Posted: December 28, 2020
Last Verified: December 1, 2020
Keywords provided by National Institutes of Health Clinical Center (CC):
Patello-Femoral
Knee
Motion
MRI
Kinematics
Additional relevant MeSH terms:
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Patellofemoral Pain Syndrome
Joint Diseases
Musculoskeletal Diseases