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

March 17, 2017 updated by: Zimmer Biomet

A Feasibility Study to Determine the Up-regulation of Anti-inflammatory Cytokines in Whole Blood From Patients With Osteoarthritis

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 4646237
        • OrthoIndy
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • Orthopaedic Surgery, Kentucky Clinic
    • Ohio
      • Columbus, Ohio, United States, 43221
        • Ohio State University Sports Medicine Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with evidence of osteoarthritis.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
osteoarthritis patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure anti-inflammatory cytokines
Time Frame: immediately after processing
immediately after processing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

January 14, 2010

First Submitted That Met QC Criteria

January 15, 2010

First Posted (Estimate)

January 18, 2010

Study Record Updates

Last Update Posted (Actual)

March 21, 2017

Last Update Submitted That Met QC Criteria

March 17, 2017

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APS-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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