Knee OsteoarthritisSFCLNCT00912106
Analyzing Composition and Lubrication Properties of Synovial Fluid
An observational study of Knee Osteoarthritis and HA Injection, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
To analyze the relationship between composition of synovial fluid and its lubrication properties Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis, HA Injection, One Injection Per Week for Five Week
- What is being tested?
- Synovial fluid composition and lubrication analysis
- Type of treatment
- Injection or infusion
- How many people
- 55 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2008to Jun 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who are going to receive HA injection of one or two knees
Who may be able to join
- Patients who are going to receive HA injection of one or two knees
Who cannot join
- Patients whose quantity of synovial fluid is not enough to be drawn
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Knee Osteoarthritis, HA Injection, One Injection Per Week for Five Week, Synovial Fluid Composition, Synovial Fluid Lubrication
- Being tested
- Synovial fluid composition and lubrication analysis
- Keywords
- osteoarthritis, HA, synovial fluid, lubrication
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synovial fluid composition and lubrication analysisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| HA injection | Patients with osteoarthritis of knee. They are going to received HA injection 1 vial per week for 5 weeks. Receives: Other: Synovial fluid composition and lubrication analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Synovial fluid HA and albumin concentration; synovial fluid lubrication
Measured: 1 wk, 2 wk, 3 wk, 4 wk, 5 wk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startApr 2008
- Primary completionDec 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science Concil
- Investigators
- Chih-Hung Chang, Ph. D, Study director, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912106
- Sponsor's protocol ID
- 96024
- Other IDs
- NSC-96-
- Acronym
- SFCL
- Status last verified
- Jun 2009
- First submitted
- 2 Jun 2009
- Last updated
- 3 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boundary Lubrication of Synovial Fluid Molecules and Its Effect on the Surrounding Cells and Tissues
- ClinicalTrials.gov ID
- NCT00912106
- Acronym / sponsor ID
- SFCL / 96024
- Conditions
- Knee Osteoarthritis, HA Injection, One Injection Per Week for Five Week, Synovial Fluid Composition, Synovial Fluid Lubrication
- Keywords
- osteoarthritis, HA, synovial fluid, lubrication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Collaborators
- National Science Concil
- Study start
- Apr 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 3 Jun 2009 (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.
To analyze the relationship between composition of synovial fluid and its lubrication properties
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HA injection | – | Other: Synovial fluid composition and lubrication analysisPatients with osteoarthritis of knee. They are going to received HA injection 1 vial per week for 5 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are going to receive HA injection of one or two knees
Key inclusion criteria (1 listed)
- Patients who are going to receive HA injection of one or two knees
Key exclusion criteria (1 listed)
- Patients whose quantity of synovial fluid is not enough to be drawn
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 |
|---|---|---|
| Synovial fluid composition and lubrication analysisBefore 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. | Other | HA injection |
Primary outcome
Synovial fluid HA and albumin concentration; synovial fluid lubrication
Time frame: 1 wk, 2 wk, 3 wk, 4 wk, 5 wk
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2009.
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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.
Chih-Hung Chang, Ph. D study director
Far Eastern Memorial 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 Knee Osteoarthritis and HA Injection, run by Far Eastern Memorial 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 3 Jun 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Synovial fluid HA and albumin concentration; synovial fluid lubrication (time frame: 1 wk, 2 wk, 3 wk, 4 wk, 5 wk). 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 3 Jun 2009.