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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01050894
Recruitment Status : Completed
First Posted : January 18, 2010
Last Update Posted : March 21, 2017
Information provided by (Responsible Party):
Zimmer Biomet

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

Condition or disease

Study Type : Observational
Actual Enrollment : 105 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Feasibility Study to Determine the Up-regulation of Anti-inflammatory Cytokines in Whole Blood From Patients With Osteoarthritis
Study Start Date : May 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

osteoarthritis patients

Primary Outcome Measures :
  1. Measure anti-inflammatory cytokines [ Time Frame: immediately after processing ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with evidence of osteoarthritis.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01050894

United States, Indiana
Indianapolis, Indiana, United States, 4646237
United States, Kentucky
Orthopaedic Surgery, Kentucky Clinic
Lexington, Kentucky, United States, 40506
United States, Ohio
Ohio State University Sports Medicine Center
Columbus, Ohio, United States, 43221
Sponsors and Collaborators
Zimmer Biomet

Responsible Party: Zimmer Biomet Identifier: NCT01050894     History of Changes
Other Study ID Numbers: APS-001
First Posted: January 18, 2010    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: December 2012

Keywords provided by Zimmer Biomet:

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anti-Inflammatory Agents