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

NCT01618149 | Unknown DMC

• 1 other identifier: 201204035RIB
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Periprosthetic Bone Loss in Total Knee Replacement

Keywords

osteoarthritis; periprosthetic bone loss; dual energy x-ray absorptiometry

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

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

Interventions

dual energy x-ray absorptiometry RADIATION

before the surgery of total knee arthroplasty and after the surgery 6 months and 12 months

severe knee OA who are indicated for total knee arthroplasty

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• severe knee osteoarthritis
• post menopausal women

You may not qualify if:

• immune disease
• end stage of renal disease who receive dialysis
• history of fracture at ipsilateral distal femur

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National taiwan university hospital

Taipei, Taiwan, 100, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

A 2X1X0.5cm bone fragment harvested during the chamfer cut of total knee arthroplasty

MeSH Terms

Conditions

Osteoarthritis

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• ching chuan Jiang, professor

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ching Chuan Jiang, professor

CONTACT

23123456; ccj@ntu.edu.tw

Wei cheng Huang, resident

CONTACT

osteocheng@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Use dual-energy x-ray absorptiometry and quantative microradiography to predict the periprosthetic bone loss in distal femur after total knee arthroplasty

Study Record Dates

• First Submitted: June 11, 2012
• First Posted: June 13, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: June 13, 2012

Record last verified: 2012-06

Locations

TW (1)