NCT01050894CompletedNot Applicable
A Feasibility Study to Determine the Up-regulation of Anti-inflammatory Cytokines in Whole Blood From Patients With Osteoarthritis
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Zimmer Biomet
- Enrollment
- 105
- Locations
- 3
- Primary Endpoint
- Measure anti-inflammatory cytokines
Study Overview
Brief Summary
This is a feasibility study to determine if anti-inflammatory cytokines can be concentrated from patients with osteoarthritis.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •radiographic evidence of osteoarthritis
- •signed informed consent
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Measure anti-inflammatory cytokines
Time Frame: immediately after processing
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (3)
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