Feasibility Study of Anti-inflammatory Cytokines in Whole Blood in Osteoarthritis Patients
A Feasibility Study to Determine the Up-regulation of Anti-inflammatory Cytokines in Whole Blood From Patients With Osteoarthritis
1 other identifier
observational
105
1 country
3
Brief Summary
This is a feasibility study to determine if anti-inflammatory cytokines can be concentrated from patients with osteoarthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2010
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2010
CompletedFirst Posted
Study publicly available on registry
January 18, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedMarch 21, 2017
December 1, 2012
1.7 years
January 14, 2010
March 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure anti-inflammatory cytokines
immediately after processing
Study Arms (1)
osteoarthritis patients
Eligibility Criteria
Patients with evidence of osteoarthritis.
You may qualify if:
- radiographic evidence of osteoarthritis
- signed informed consent
You may not qualify if:
- Pregnancy
- \< 18 years of age
- blood clotting disorder or active hematologic cancer
- undergoing chemotherapy
- history of rheumatoid arthritis
- septic joint or fracture
- active infection or history of chronic infection
- use of cytokine blocking drugs with the last 6 months
- intra-articular steroid or hyaluronic acid (HA) injection within last 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zimmer Biometlead
Study Sites (3)
OrthoIndy
Indianapolis, Indiana, 4646237, United States
Orthopaedic Surgery, Kentucky Clinic
Lexington, Kentucky, 40506, United States
Ohio State University Sports Medicine Center
Columbus, Ohio, 43221, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2010
First Posted
January 18, 2010
Study Start
May 1, 2010
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
March 21, 2017
Record last verified: 2012-12