- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01618149
Use Quantitative Microradiography to Predict the Periprosthetic Bone Loss in Distal Femur After Total Knee Arthroplasty
June 12, 2012 updated by: National Taiwan University Hospital
Use Dual-energy X-ray Absorptiometry and Quantitative Microradiography to Predict the Periprosthetic Bone Loss in Distal Femur After Total Knee Arthroplasty
The investigators hypothesized that the microarchitecture of bone influence the degree of periprosthetic bone loss after total knee arthroplasty surgery.
The investigators collected the bone fragment at the distal femur while performing total knee replacement and take quantitative radiography analysis .
Before and after the surgery(6 month ,12 month) , the investigators check the BMD at identical location of the distal femur by using dual energy absorptiometry.
The investigators will use linear regression to evaluate the relationship between the microarchitecture and the degree of bone loss.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
50
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
-
-
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Taipei, Taiwan, 100
- National Taiwan University Hospital
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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
50 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
the patients who are indicated for total knee arthroplasty and are post menopausal women.
The patients who had history of immune disease , fracture of the femur and end stage of renal disease will be excluded
Description
Inclusion Criteria:
- severe knee osteoarthritis
- post menopausal women
Exclusion Criteria:
- immune disease
- end stage of renal disease who receive dialysis
- history of fracture at ipsilateral distal femur
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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severe knee OA who are indicated for total knee arthroplasty
the woman who are indicated for TKR and are post menopausal will be recruited in this study.
We will excluded the patients who had immune disease ,previous fracture of femur and end stage of renal disease
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before the surgery of total knee arthroplasty and after the surgery 6 months and 12 months
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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change in bone mineral density
Time Frame: before the surgery and after the sugery (6month ,12month)
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Use dual energy x-ray absorptiometry to detect to BMD at the distal femur
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before the surgery and after the sugery (6month ,12month)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: ching chuan Jiang, professor, National Taiwan University Hospital
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
July 1, 2012
Primary Completion (Anticipated)
July 1, 2013
Study Completion (Anticipated)
July 1, 2013
Study Registration Dates
First Submitted
June 11, 2012
First Submitted That Met QC Criteria
June 12, 2012
First Posted (Estimate)
June 13, 2012
Study Record Updates
Last Update Posted (Estimate)
June 13, 2012
Last Update Submitted That Met QC Criteria
June 12, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201204035RIB
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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