NCT01050894

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2010

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

March 21, 2017

Status Verified

December 1, 2012

Enrollment Period

1.7 years

First QC Date

January 14, 2010

Last Update Submit

March 17, 2017

Conditions

Keywords

osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Measure anti-inflammatory cytokines

    immediately after processing

Study Arms (1)

osteoarthritis patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with evidence of osteoarthritis.

You may qualify if:

  • radiographic evidence of osteoarthritis
  • signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

OrthoIndy

Indianapolis, Indiana, 4646237, United States

Location

Orthopaedic Surgery, Kentucky Clinic

Lexington, Kentucky, 40506, United States

Location

Ohio State University Sports Medicine Center

Columbus, Ohio, 43221, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2010

First Posted

January 18, 2010

Study Start

May 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

March 21, 2017

Record last verified: 2012-12

Locations