Feasibility Study of Anti-inflammatory Cytokines in Whole Blood in Osteoarthritis Patients

Completed

• Conditions: Osteoarthritis

• Registration Number: NCT01050894
• Lead Sponsor: Zimmer Biomet

Brief Summary

This is a feasibility study to determine if anti-inflammatory cytokines can be concentrated from patients with osteoarthritis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-14
• Study First Submitted QC: 2010-01-15
• Study First Posted: 2010-01-18
• Study Start: 2010-05
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-12
• Last Update Submitted: 2017-03-17
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure anti-inflammatory cytokines	immediately after processing

Trial Locations

Locations (3)

Orthopaedic Surgery, Kentucky Clinic; 🇺🇸 Lexington, Kentucky, United States

Ohio State University Sports Medicine Center; 🇺🇸 Columbus, Ohio, United States

OrthoIndy; 🇺🇸 Indianapolis, Indiana, United States