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

NCT ID: NCT01050894

Last Updated: 2017-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-01-31

Brief Summary

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

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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osteoarthritis patients

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zimmer Biomet

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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OrthoIndy

Indianapolis, Indiana, United States

Site Status

Orthopaedic Surgery, Kentucky Clinic

Lexington, Kentucky, United States

Site Status

Ohio State University Sports Medicine Center

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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APS-001

Identifier Type: -

Identifier Source: org_study_id

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