Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00051857
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2003-01-16
Brief Title:
MRI Study of Musculoskeletal Function
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Virtual Function Anatomy VFA
Status:
RECRUITING
Status Verified Date:
2024-07-29
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
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 eg 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 muscle 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 subjects 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 eg 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 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 eg 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
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-CC-0060 | None | None | None |