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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01050894
First Posted: January 18, 2010
Last Update Posted: March 21, 2017
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.
Information provided by (Responsible Party):
Zimmer Biomet
  Purpose
This is a feasibility study to determine if anti-inflammatory cytokines can be concentrated from patients with osteoarthritis.

Condition
Osteoarthritis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Zimmer Biomet:

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

Enrollment: 105
Study Start Date: May 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
osteoarthritis patients

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01050894


Locations
United States, Indiana
OrthoIndy
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
  More Information

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01050894     History of Changes
Other Study ID Numbers: APS-001
First Submitted: January 14, 2010
First Posted: January 18, 2010
Last Update Posted: March 21, 2017
Last Verified: December 2012

Keywords provided by Zimmer Biomet:
osteoarthritis

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