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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01050894
First received: January 14, 2010
Last updated: December 18, 2012
Last verified: December 2012
  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 Biomet, Inc.:

Primary Outcome Measures:
  • Measure anti-inflammatory cytokines [ Time Frame: immediately after processing ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Biomet, Inc.
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01050894     History of Changes
Other Study ID Numbers: APS-001
Study First Received: January 14, 2010
Last Updated: December 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Biomet, Inc.:
osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014