OsteoarthritisNCT02664870
Evaluation of Biomarkers in Human Synovial Fluid
An observational study of Osteoarthritis, run by Duke University at 1 site in United States.
Trial summary
Osteoarthritis is a condition that causes joints in the human body to deteriorate over time. This condition affects more than 250 million people around the globe. Currently, the goal of treating osteoarthritis involves reducing the severity and pain that results from the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Arthroscopy and Arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 1 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited at the Sports Medicine and Adult Reconstruction Clinics at Duke University Medical Center.
Who may be able to join
- Adult patients ( > 18 years old)
- Patient is eligible for general anesthesia and either arthroscopy or arthroplasty.
- Patient needs standard of care arthroscopy or arthroplasty of either shoulder, hip or knee joint for osteoarthritis or prearthritic conditions.
- Patient must have signed an IRB approved informed consent document for the arthrocentesis procedure which will be performed during the arthroscopic or arthroplastic procedure.
Who cannot join
- Active Joint Infection within last 6 months.
- Previous arthroplasty in the joint undergoing arthroplasty
- History of auto-immune arthropathies.
- History of HIV or Hepatitis C
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Biological and Clinical Databank for the Evaluation of Biomarkers in Human Synovial Fluid
Osteoarthritis is a condition that causes joints in the human body to deteriorate over time. This condition affects more than 250 million people around the globe. Currently, the goal of treating osteoarthritis involves reducing the severity and pain that results from the disease. The ultimate goal of this study is to identify patients with pre-arthritic joints (before symptoms or disease characteristics appear) in an effort to find and use treatments that stop or slow the disease. Joints are filled with a naturally occurring liquid known as synovial fluid. Molecules (biomarkers) and genetic expression of various cell types within synovial joint fluid may serve as measures of onset and progression of osteoarthritis. These samples have the potential to improve diagnosis, classification, and treatment, possibly changing the natural history of this debilitating disease. The purpose of this study is to develop a collection of synovial fluid samples from the shoulder, hip and knee for the analysis of biomarkers and cellular and genetic components therein to better understand the pre-arthritic joint, progression to disease, and response to interventions.
- Conditions
- Osteoarthritis
- Being tested
- Arthroscopy, Arthroplasty
- Keywords
- synovial fluid, biomarkers
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArthroscopyProcedure or surgery
Arthroscopic Surgery on the hip, shoulder, or knee
ArthroplastyProcedure or surgery
Total hip, shoulder, or knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Shoulder Patients | Patients (1) without evidence of cartilage damage, (2) with molecular change, (3) physiologic change, or (4) with end-stage osteoarthritis, who require arthroscopy or arthroplasty Receives: Procedure: Arthroscopy; Procedure: Arthroplasty | |
| Hip Patients | Patients (1) without evidence of cartilage damage, (2) with molecular change, (3) physiologic change, or (4) with end-stage osteoarthritis, who require arthroscopy (with or without periacetabular osteotomy (PAO)) or arthroplasty Receives: Procedure: Arthroscopy; Procedure: Arthroplasty | |
| Knee Patients | Patients (1) without evidence of cartilage damage, (2) with molecular change, (3) physiologic change, or (4) with end-stage osteoarthritis, who require arthroscopy or arthroplasty Receives: Procedure: Arthroscopy; Procedure: Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of biobank data collection as measured by percentage of patients with a complete data set one year post-operation
Study participants will be enrolled over an anticipated time frame of 2 years. One year following the last participant's enrollment prompts an anticipated three year time frame to determine the feasibility of biobank data collection.
Measured: 1 year
Secondary outcomes (4)
Number of biomarkers worthy of study to aid in the diagnosis and progression of osteoarthritis
Biomarkers for study include the following: CRP, Eotaxin, Eotaxin-3, FGF (basic), Flt-1/VEGFR1, GM-CSF, ICAM-1, IFN-γ, IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A, IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IP-10, MCP-1, MCP-4, MDC, MIP-1α, MIP-1β, PlGF, SAA, TARC, Tie-2, TNF-α, TNF-β, VCAM-1, VEGF-A, VEGF-C, VEGF-D, clusterin, lubricin, and matrix molecules.
Measured: 3-5 years
Types of biomarkers worthy of study to aid in the diagnosis and progression of osteoarthritis
Types of biomarkers include the following: chemokines, cytokines, inflammatory, angiogenesis, and vascular injury.
Measured: 3-5 years
Number of patients who responded to non-arthroplasty intervention based on biomarker analysis and measured with questionnaires
Measured: 1-10 years
Number of patients who did not respond to non-arthroplasty intervention based on biomarker analysis and measured with questionnaires
Measured: 1-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startJan 2016
- Primary completion24 Jan 2019
- Study completion1 Jan 2028 (estimated)
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 Duke UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard C. Mather, MD, MBA, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664870
- Sponsor's protocol ID
- Pro00066468
- Status last verified
- Feb 2026
- First submitted
- 7 Jan 2016
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Biological and Clinical Databank for the Evaluation of Biomarkers in Human Synovial Fluid
- ClinicalTrials.gov ID
- NCT02664870
- Acronym / sponsor ID
- Pro00066468
- Conditions
- Osteoarthritis
- Keywords
- synovial fluid, biomarkers
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 24 Jan 2019 (actual)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 27 Jan 2016 (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.
Osteoarthritis is a condition that causes joints in the human body to deteriorate over time. This condition affects more than 250 million people around the globe. Currently, the goal of treating osteoarthritis involves reducing the severity and pain that results from the disease. The ultimate goal of this study is to identify patients with pre-arthritic joints (before symptoms or disease characteristics appear) in an effort to find and use treatments that stop or slow the disease. Joints are filled with a naturally occurring liquid known as synovial fluid. Molecules (biomarkers) and genetic expression of various cell types within synovial joint fluid may serve as measures of onset and progression of osteoarthritis. These samples have the potential to improve diagnosis, classification, and treatment, possibly changing the natural history of this debilitating disease. The purpose of this study is to develop a collection of synovial fluid samples from the shoulder, hip and knee for the analysis of biomarkers and cellular and genetic components therein to better understand the pre-arthritic joint, progression to disease, and response to interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Shoulder Patients | – | Procedure: Arthroscopy, Procedure: ArthroplastyPatients (1) without evidence of cartilage damage, (2) with molecular change, (3) physiologic change, or (4) with end-stage osteoarthritis, who require arthroscopy or arthroplasty |
| Hip Patients | – | Procedure: Arthroscopy, Procedure: ArthroplastyPatients (1) without evidence of cartilage damage, (2) with molecular change, (3) physiologic change, or (4) with end-stage osteoarthritis, who require arthroscopy (with or without periacetabular osteotomy (PAO)) or arthroplasty |
| Knee Patients | – | Procedure: Arthroscopy, Procedure: ArthroplastyPatients (1) without evidence of cartilage damage, (2) with molecular change, (3) physiologic change, or (4) with end-stage osteoarthritis, who require arthroscopy or arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited at the Sports Medicine and Adult Reconstruction Clinics at Duke University Medical Center.
Key inclusion criteria (4 listed)
- Adult patients ( > 18 years old)
- Patient is eligible for general anesthesia and either arthroscopy or arthroplasty.
- Patient needs standard of care arthroscopy or arthroplasty of either shoulder, hip or knee joint for osteoarthritis or prearthritic conditions.
- Patient must have signed an IRB approved informed consent document for the arthrocentesis procedure which will be performed during the arthroscopic or arthroplastic procedure.
Key exclusion criteria (4 listed)
- Active Joint Infection within last 6 months.
- Previous arthroplasty in the joint undergoing arthroplasty
- History of auto-immune arthropathies.
- History of HIV or Hepatitis C
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArthroscopyArthroscopic Surgery on the hip, shoulder, or knee | Procedure or surgery | Hip Patients, Knee Patients, Shoulder Patients |
| ArthroplastyTotal hip, shoulder, or knee arthroplasty | Procedure or surgery | Hip Patients, Knee Patients, Shoulder Patients |
Primary outcome
Feasibility of biobank data collection as measured by percentage of patients with a complete data set one year post-operation
Time frame: 1 year
Study participants will be enrolled over an anticipated time frame of 2 years. One year following the last participant's enrollment prompts an anticipated three year time frame to determine the feasibility of biobank data collection.
4 secondary outcomes
Number of biomarkers worthy of study to aid in the diagnosis and progression of osteoarthritis
Time frame: 3-5 years
Types of biomarkers worthy of study to aid in the diagnosis and progression of osteoarthritis
Time frame: 3-5 years
Number of patients who responded to non-arthroplasty intervention based on biomarker analysis and measured with questionnaires
Time frame: 1-10 years
Number of patients who did not respond to non-arthroplasty intervention based on biomarker analysis and measured with questionnaires
Time frame: 1-10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
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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.
Richard C. Mather, MD, MBA principal investigator
Duke University
1 site 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 Duke University at 1 site 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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Feasibility of biobank data collection as measured by percentage of patients with a complete data set one year post-operation (time frame: 1 year). 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 4 Feb 2026.