OsteoarthritisNCT01050894
Feasibility Study of Anti-inflammatory Cytokines in Whole Blood in Osteoarthritis Patients
An observational study of Osteoarthritis, run by Zimmer Biomet at 3 sites in United States.
Trial summary
This is a feasibility study to determine if anti-inflammatory cytokines can be concentrated from patients with osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- How many people
- 105 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2010to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with evidence of osteoarthritis.
Who may be able to join
- radiographic evidence of osteoarthritis
- signed informed consent
Who cannot join
- Pregnancy
- < 18 years of age
- blood clotting disorder or active hematologic cancer
- undergoing chemotherapy
- history of rheumatoid arthritis
- septic joint or fracture
Show all 9Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Ohio State University Sports Medicine Center
Columbus, Ohio, 43221
OrthoIndy
Indianapolis, Indiana, 4646237
Orthopaedic Surgery, Kentucky Clinic
Lexington, Kentucky, 40506
About this study
Official title: 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.
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| osteoarthritis patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure anti-inflammatory cytokines
Measured: immediately after processing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2010 (estimated)
- Study startMay 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050894
- Sponsor's protocol ID
- APS-001
- Status last verified
- Dec 2012
- First submitted
- 14 Jan 2010
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Determine the Up-regulation of Anti-inflammatory Cytokines in Whole Blood From Patients With Osteoarthritis
- ClinicalTrials.gov ID
- NCT01050894
- Acronym / sponsor ID
- APS-001
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 18 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a feasibility study to determine if anti-inflammatory cytokines can be concentrated from patients with osteoarthritis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| osteoarthritis patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with evidence of osteoarthritis.
Key inclusion criteria (2 listed)
- radiographic evidence of osteoarthritis
- signed informed consent
Key exclusion criteria (9 listed)
- Pregnancy
- < 18 years of age
- blood clotting disorder or active hematologic cancer
- undergoing chemotherapy
- history of rheumatoid arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure anti-inflammatory cytokines
Time frame: immediately after processing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Zimmer Biomet at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure anti-inflammatory cytokines (time frame: immediately after processing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2017.