Periprosthetic Bone Loss in Total Knee ReplacementNCT01618149
Use Quantitative Microradiography to Predict the Periprosthetic Bone Loss in Distal Femur After Total Knee Arthroplasty
An observational study of Periprosthetic Bone Loss in Total Knee Replacement, run by National Taiwan University Hospital at 1 site in Taiwan.
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 . Read more about this study
- Who is it for?
- Ages 50 to 70 years, women only
- Conditions the study is for
- Periprosthetic Bone Loss in Total Knee Replacement
- What is being tested?
- dual energy x-ray absorptiometry
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2012to Jul 2013
- 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 50 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- severe knee osteoarthritis
- post menopausal women
Who cannot join
- immune disease
- end stage of renal disease who receive dialysis
- history of fracture at ipsilateral distal femur
Trial locations and contacts
1 site in 1 country.
Wei cheng Huang, resident contact
Taiwan1 site
National taiwan university hospital
Taipei, Taiwan, 100
Ching Chuan Jiang, professoir, 886223123456 ext. 65273, ccj@ntu.edu.tw
About this study
Official title: 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.
- Being tested
- dual energy x-ray absorptiometry
- Keywords
- osteoarthritis, periprosthetic bone loss, dual energy x-ray absorptiometry
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual energy x-ray absorptiometryRadiation
before the surgery of total knee arthroplasty and after the surgery 6 months and 12 months
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: dual energy x-ray absorptiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in bone mineral density
Use dual energy x-ray absorptiometry to detect to BMD at the distal femur
Measured: before the surgery and after the sugery (6month ,12month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periprosthetic Bone Loss in Total Knee ReplacementStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, National Taiwan University Hospital, National Taiwan University Hospital
- Investigators
- ching chuan Jiang, professor, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618149
- Sponsor's protocol ID
- 201204035RIB
- Status last verified
- Jun 2012
- First submitted
- 11 Jun 2012
- Last updated
- 13 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use Dual-energy X-ray Absorptiometry and Quantitative Microradiography to Predict the Periprosthetic Bone Loss in Distal Femur After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01618149
- Acronym / sponsor ID
- 201204035RIB
- Keywords
- osteoarthritis, periprosthetic bone loss, dual energy x-ray absorptiometry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 13 Jun 2012 (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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| severe knee OA who are indicated for total knee arthroplasty | – | Radiation: dual energy x-ray absorptiometrythe 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 |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- severe knee osteoarthritis
- post menopausal women
Key exclusion criteria (3 listed)
- immune disease
- end stage of renal disease who receive dialysis
- history of fracture at ipsilateral distal femur
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 |
|---|---|---|
| dual energy x-ray absorptiometrybefore the surgery of total knee arthroplasty and after the surgery 6 months and 12 months | Radiation | severe knee OA who are indicated for total knee arthroplasty |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2012.
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.
Wei cheng Huang, resident contact
ching chuan Jiang, professor principal investigator
National Taiwan University Hospital
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 Periprosthetic Bone Loss in Total Knee Replacement, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Jun 2012. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ching Chuan Jiang, professor (23123456 ext. 65273, ccj@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in bone mineral density (time frame: before the surgery and after the sugery (6month ,12month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2012.