HealthyNCT00581841
Repeatability of X-Ray, MRI, and Gait Analysis
An observational study of Healthy, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Gait analysis, knee x-ray, and knee MRI
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Jun 2003
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample
Who may be able to join
- Healthy adults
Who cannot join
- Previous knee injury, knee pain, or knee osteoarthritis
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Gait analysis, knee x-ray, and knee MRI
- Keywords
- Healthy adult normals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait analysis, knee x-ray, and knee MRIOther
Gait analysis, knee x-rays, and knee MRIs will be done twice for each participant, 1 week apart.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Healthy adult participants with no history of knee injury or osteoarthritis. Receives: Other: Gait analysis, knee x-ray, and knee MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day-to-day and inter/intra examiner repeatability of the techniques to be used in NIH grant R01 AR48768
Measured: Measured two times, with a 1-week period between evaluations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startNov 2002
- Primary completionJun 2003
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Investigators
- Kenton R. Kaufman, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581841
- Sponsor's protocol ID
- R01 AR48768 - substudy
- Other IDs
- R01AR048768, NIAMS-081-1
- Status last verified
- May 2013
- First submitted
- 21 Dec 2007
- Last updated
- 17 May 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 15915340Grochowski 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.
PubMed 16021447Koff 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.
PubMed 16949313Agnesi 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.
PubMed 17242952
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeatability of X-Ray, MRI, and Gait Analysis
- ClinicalTrials.gov ID
- NCT00581841
- Acronym / sponsor ID
- R01 AR48768 - substudy
- Conditions
- Healthy
- Keywords
- Healthy adult normals
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Nov 2002
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 28 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Gait analysis, knee x-ray, and knee MRIHealthy adult participants with no history of knee injury or osteoarthritis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (1 listed)
- Healthy adults
Key exclusion criteria (1 listed)
- Previous knee injury, knee pain, or knee osteoarthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait analysis, knee x-ray, and knee MRIGait analysis, knee x-rays, and knee MRIs will be done twice for each participant, 1 week apart. | Other | 1 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2013.
- Background: PubMed 15915340Schmidt 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.
- Background: PubMed 16021447Grochowski 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.
- Background: PubMed 16949313Koff 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.
- Background: PubMed 17242952Agnesi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenton R. Kaufman, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00581841, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2013.