- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00581841
Repeatability of X-Ray, MRI, and Gait Analysis
May 16, 2013 updated by: Mayo Clinic
The purpose of this preliminary substudy to the parent study "Aerobic Exercise Intervention for Knee Osteoarthritis" is to determine the repeatability and reproducibility of various measurement techniques.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this preliminary substudy to the parent study "Aerobic Exercise Intervention for Knee Osteoarthritis" is to determine the repeatability and reproducibility of various measurement techniques.
The study will enroll healthy volunteers.
All participants will receive x-rays and MRI examinations of the knees.
Walking characteristics will be evaluated in a Motion Analysis Lab; this will involve taping reflective markers to participants' skin and having them walk on a level surface and up and down stairs.
All participants will be evaluated two times, with a 1-week period between evaluations.
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Community sample
Description
Inclusion Criteria:
- Healthy adults
Exclusion Criteria:
- Previous knee injury, knee pain, or knee osteoarthritis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
Healthy adult participants with no history of knee injury or osteoarthritis.
|
Gait analysis, knee x-rays, and knee MRIs will be done twice for each participant, 1 week apart.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Day-to-day and inter/intra examiner repeatability of the techniques to be used in NIH grant R01 AR48768
Time Frame: Measured two times, with a 1-week period between evaluations
|
Measured two times, with a 1-week period between evaluations
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kenton R. Kaufman, PhD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Schmidt JE, Amrami KK, Manduca A, Kaufman KR. Semi-automated digital image analysis of joint space width in knee radiographs. Skeletal Radiol. 2005 Oct;34(10):639-43. doi: 10.1007/s00256-005-0908-9. Epub 2005 May 25.
- Grochowski SJ, Amrami KK, Kaufman K. Semi-automated digital image analysis of patellofemoral joint space width from lateral knee radiographs. Skeletal Radiol. 2005 Oct;34(10):644-8. doi: 10.1007/s00256-005-0944-5. Epub 2005 Jul 15.
- Koff MF, Amrami KK, Kaufman KR. Clinical evaluation of T2 values of patellar cartilage in patients with osteoarthritis. Osteoarthritis Cartilage. 2007 Feb;15(2):198-204. doi: 10.1016/j.joca.2006.07.007. Epub 2006 Sep 1.
- Agnesi F, Amrami KK, Frigo CA, Kaufman KR. Semiautomated digital analysis of knee joint space width using MR images. Skeletal Radiol. 2007 May;36(5):437-44. doi: 10.1007/s00256-006-0245-7. Epub 2007 Jan 23.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2002
Primary Completion (Actual)
June 1, 2003
Study Completion (Actual)
June 1, 2003
Study Registration Dates
First Submitted
December 21, 2007
First Submitted That Met QC Criteria
December 27, 2007
First Posted (Estimate)
December 28, 2007
Study Record Updates
Last Update Posted (Estimate)
May 17, 2013
Last Update Submitted That Met QC Criteria
May 16, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R01 AR48768 - substudy
- R01AR048768 (U.S. NIH Grant/Contract)
- NIAMS-081-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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