- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00912106
Analyzing Composition and Lubrication Properties of Synovial Fluid (SFCL)
June 2, 2009 updated by: Far Eastern Memorial Hospital
Boundary Lubrication of Synovial Fluid Molecules and Its Effect on the Surrounding Cells and Tissues
To analyze the relationship between composition of synovial fluid and its lubrication properties
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients suffering from serious arthritis may receive the artificial joint replacement surgery.
Comparing to the articulation of articular cartilage, the artificial joint undergo a boundary lubrication in which a thin layer of synovial fluid molecules is formed between the artificial joint materials.
Therefore a larger wear rate is observed in the artificial joint system.
Researchers have devoted themselves to modifying the artificial joint materials in order to reduce the wear phenomena.
We first propose that modification the lubrication by adding effective lubricating molecules may help to reduce the wear of artificial joint.
However, there still lacks fundamentally understanding of the artificial joint lubrication mechanism under synovial fluid.
Hence, we plan to investigate the boundary lubrication mechanism of synovial molecules, such as albumin, globulin, hyaluronic acid, and lipid in the first year.
We would like to obtain the adsorption behaviors of the single molecules as well as multiple molecules on the surfaces of artificial joint materials by experiments.
Molecular dynamics simulation will also be performed to gain the knowledge of adsorption energy and possible conformation change of the molecules.
In the second year, the tribological heat and mechanical effects on the synovial molecules will be studied.
The analysis platform will be established to perform the composition and properties measurement of the synovial molecules.
In the third year, we will further discuss the effect of the synovial molecules transformation on the surrounding cells and tissues.
Their influences on the tribological and biochemical behaviors will be investigated.
Study Type
Observational
Enrollment (Actual)
55
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
-
-
Taipei
-
Pan-Ciao, Taipei, Taiwan, 22050
- Far Eastern Memorial Hospital
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients who are going to receive HA injection of one or two knees
Description
Inclusion Criteria:
- Patients who are going to receive HA injection of one or two knees
Exclusion Criteria:
- Patients whose quantity of synovial fluid is not enough to be drawn
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: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
HA injection
Patients with osteoarthritis of knee.
They are going to received HA injection 1 vial per week for 5 weeks.
|
Before HA injection, synovial fluid must be drawn to increase treatment effectiveness.
The drawn synovial fluid was then analyzed in the lab.
There was no influence for patients enrolled because the drawn synovial fluid would usually be discarded.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Synovial fluid HA and albumin concentration; synovial fluid lubrication
Time Frame: 1 wk, 2 wk, 3 wk, 4 wk, 5 wk
|
1 wk, 2 wk, 3 wk, 4 wk, 5 wk
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Chih-Hung Chang, Ph. D, Far Eastern Memorial 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
April 1, 2008
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
June 2, 2009
First Submitted That Met QC Criteria
June 2, 2009
First Posted (Estimate)
June 3, 2009
Study Record Updates
Last Update Posted (Estimate)
June 3, 2009
Last Update Submitted That Met QC Criteria
June 2, 2009
Last Verified
June 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 96024
- NSC-96-
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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