Analyzing Composition and Lubrication Properties of Synovial Fluid (SFCL)

• ClinicalTrials.gov Identifier: NCT00912106
• Recruitment Status: Completed
• First Posted: June 3, 2009
• Last Update Posted: June 3, 2009
• Sponsor: Far Eastern Memorial Hospital
• Collaborator: National Science Concil
• Information provided by: Far Eastern Memorial Hospital

Tracking Information

• First Submitted Date: June 2, 2009
• First Posted Date: June 3, 2009
• Last Update Posted Date: June 3, 2009
• Study Start Date: April 2008
• Actual Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 2, 2009): Synovial fluid HA and albumin concentration; synovial fluid lubrication [ Time Frame: 1 wk, 2 wk, 3 wk, 4 wk, 5 wk ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Analyzing Composition and Lubrication Properties of Synovial Fluid
• Official Title: Boundary Lubrication of Synovial Fluid Molecules and Its Effect on the Surrounding Cells and Tissues
• Brief Summary: 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 Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

synovial fluid from knee joint

• Sampling Method: Probability Sample
• Study Population: Patients who are going to receive HA injection of one or two knees

Condition

• Knee Osteoarthritis
• HA Injection
• One Injection Per Week for Five Week
• Synovial Fluid Composition
• Synovial Fluid Lubrication

Intervention

Other: Synovial fluid composition and lubrication analysis

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 Groups/Cohorts

HA injection

Patients with osteoarthritis of knee. They are going to received HA injection 1 vial per week for 5 weeks.

Intervention: Other: Synovial fluid composition and lubrication analysis

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 2, 2009): 55
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: June 2009
• Actual Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT00912106
• Other Study ID Numbers: 96024; NSC-96-
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Chih-Hung Chang, Division of Orthopedics, Far Eastern Memorial Hospital
• Study Sponsor: Far Eastern Memorial Hospital
• Collaborators: National Science Concil

Investigators

• Study Director: Chih-Hung Chang, Ph. D; Far Eastern Memorial Hospital

• PRS Account: Far Eastern Memorial Hospital
• Verification Date: June 2009