"Is there a better way for physicians to interpret foot X-rays and diagnose foot disorders?"
x-ray, healthy volunteer
The purpose of this study is to investigate how percent of weight bearing (standing while supporting none, some, or all of your body weight on your foot) influences foot X-ray. Understanding the impact (whether or not there is a predictable pattern) that weight bearing has on X-ray examination of the bones of the foot is important to accurately diagnose foot injuries. The results of the study will allow physicians to interpret weight and non-weight bearing X-rays with better confidence and certainty.
This study requires
One-time visit to the UC Davis Medical Center. During this visit, multiple x-rays of your feet will be taken with you applying different amounts of your body weight.
Who can participate?
Inclusion Criteria: • The subject is > 18 years of age. • The subject is English speaking. • The subject is skeletally mature. • The subject is willing and able to provide written informed consent. • The subject has participated in the Informed Consent process and has signed the IRB/EC approved Informed Consent. Exclusion Criteria: • The subject is: o A prisoner o Mentally incompetent or unable to understand what participation in the study entails o A known alcohol or drug abuser • The subject has any history of prior foot surgery • The subject has an acute foot injury • The subject has current foot or ankle pain • The subject has history of foot and/or ankle arthritis • The subject has a history of inflammatory arthropathy • The subject resports current steroid use • The subject has ligamentous laxity • The subject is known to be pregnant • The subject is unwilling or unable to give consent
Benefits and risks of participating
There are no direct benefits from participating in the study.
A potential risk is the possibility of discovering an “incidental” finding on your radiographs. If any significant abnormal finding is found on radiograph, the participant will be contacted with the option for orthopaedic referral (i.e. if a stress fracture is identified). A stress fracture is a small crack in a bone.
The risk for loss of privacy is minimal. All study data is de-identified for data analysis after authorized research personnel access the electronic medical record for the purpose of obtaining the absolute minimal information to maintain enrollment logs. Accessed information includes, but is not limited to, name, date of birth, inclusion and exclusion criteria. Any unauthorized individual will not have access to protected health information, as it will be kept in a secured computer at the Cypress Building within the UC Davis Medical Center under password-protected precautions inside a locked facility.
Radiation Risks: This study involves a low radiation exposure that is equivalent to the amount of natural background radiation received by an individual in a 1 day time period. The amount of radiation exposure received in this study is below the levels that are thought to result in a significant risk of harmful effects.
What happens to the information collected for the research? Disclosure of your personal information is limited to people who need to review this information for the purpose of the study. Radiographic images will be stored on password-protected computers through the EMR at UC Davis Medical Center, so that both doctors from the Orthopedics and Radiology Department can have access for interpretation. Generated reports for data analysis by doctors will be stored under password-protected precautions inside a locked facility at the Cypress Building within the UCDMC. The reports will be used primarily for comparison for study purposes, so that we can answer our clinical question and hypothesis. Additionally, scanned consent forms and non-radiological research material (i.e. enrollment logs, manuscript, data analysis) will be stored inside the Cypress Building at UCDMC under password-protected precautions. Physical consent forms will be shredded and disposed appropriately to secure protected health information. The enrollment logs will be used to record pertinent study data from volunteers that will then be de-identified for data analysis purposes. A manuscript report will be generated after data analysis with complete de-identified data to present study findings.