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Use Quantitative Microradiography to Predict the Periprosthetic Bone Loss in Distal Femur After Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT01618149
Recruitment Status : Unknown
Verified June 2012 by National Taiwan University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 13, 2012
Last Update Posted : June 13, 2012
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Periprosthetic Bone Loss in Total Knee Replacement Radiation: dual energy x-ray absorptiometry

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use Dual-energy X-ray Absorptiometry and Quantitative Microradiography to Predict the Periprosthetic Bone Loss in Distal Femur After Total Knee Arthroplasty
Study Start Date : July 2012
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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
Radiation: dual energy x-ray absorptiometry
before the surgery of total knee arthroplasty and after the surgery 6 months and 12 months



Primary Outcome Measures :
  1. change in bone mineral density [ Time Frame: before the surgery and after the sugery (6month ,12month) ]
    Use dual energy x-ray absorptiometry to detect to BMD at the distal femur


Biospecimen Retention:   Samples With DNA
A 2X1X0.5cm bone fragment harvested during the chamfer cut of total knee arthroplasty


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01618149


Contacts
Contact: Ching Chuan Jiang, professor 23123456 ext 65273 ccj@ntu.edu.tw
Contact: Wei cheng Huang, resident osteocheng@gmail.com

Locations
Taiwan
National taiwan university hospital Not yet recruiting
Taipei, Taiwan, 100
Contact: Ching Chuan Jiang, professoir    886223123456 ext 65273    ccj@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: ching chuan Jiang, professor National Taiwan University Hospital

Responsible Party: National Taiwan University Hospital, Use dual-energy x-ray absorptiometry and quantative microradiography to predict the periprosthetic bone loss in distal femur after total knee arthroplasty
ClinicalTrials.gov Identifier: NCT01618149     History of Changes
Other Study ID Numbers: 201204035RIB
First Posted: June 13, 2012    Key Record Dates
Last Update Posted: June 13, 2012
Last Verified: June 2012

Keywords provided by National Taiwan University Hospital:
osteoarthritis
periprosthetic bone loss
dual energy x-ray absorptiometry

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases