Ultrasound Assessment of Weightbearing and Non-Weightbearing Meniscal Protrusion
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-004566
Sponsor Protocol Number: 17-004566
About this study
The purpose of this study is to determine the intra-rater and inter-rater reliability of US measurements of meniscal protrusion with and without weight bearing.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
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Healthy Knee Arm: Model inclusion criteria include being a male or female between 18 and 65 years of age who can wear shorts that allow visualization of their knees, are able to straighten their knees, lie in a supine position, and stand.
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Medial Knee OA Arm: Model inclusion criteria include being a male or female between 18 and 90 years of age with unilateral or bilateral knee medial compartment OA of at least radiographic K/L severity 2-4.
Exclusion Criteria:
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Healthy Knee Arm: Model exclusion criteria include having a lower extremity amputation, current or prior knee pain requiring activity modification or medical treatment, history of knee region fracture, body mass index (BMI) greater than 40 kg/m2, or history of knee surgery. Screening for exclusion criteria will be confirmed by oral history taking with the model candidate and BMI calculation based on height and weight information provided by the patient (described above) prior to assignment of subject ID numbers.
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Medial Knee OA Arm: Model exclusion criteria include having a lower extremity amputation, body mass index (BMI) greater than 40 kg/m2, inability to stand on affected leg or history of knee surgery. Screening for exclusion criteria will be confirmed by oral history taking with the model candidate and BMI calculation based on height and weight information provided by the patient (described above) prior to assignment of subject ID numbers.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Jonathan Finnoff, D.O. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available