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

Periprosthetic Bone Loss in Total Knee Replacement Clinical Trial

Official title:

Use Dual-energy X-ray Absorptiometry and Quantitative Microradiography to Predict the Periprosthetic Bone Loss in Distal Femur After Total Knee Arthroplasty

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01618149
• Other study ID #: 201204035RIB
• Status: Not yet recruiting
• Phase: N/A
• First received: June 11, 2012
• Last updated: June 12, 2012
• Start date: July 2012
• Est. completion date: July 2013

Study information

• Verified date: June 2012
• Source: National Taiwan University Hospital
• Contact: Ching Chuan Jiang, professor
• Phone: 23123456
• Email: ccj[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of HealthUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Periprosthetic Bone Loss in Total Knee Replacement

Intervention

Radiation:
• dual energy x-ray absorptiometry
before the surgery of total knee arthroplasty and after the surgery 6 months and 12 months

Locations

Country	Name	City	State
Taiwan	National taiwan university hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in bone mineral density	Use dual energy x-ray absorptiometry to detect to BMD at the distal femur	before the surgery and after the sugery (6month ,12month)	No