Evaluation of Biomarkers in Human Synovial Fluid

NCT ID: NCT02664870

Last Updated: 2025-02-27

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

ACTIVE_NOT_RECRUITING

Total Enrollment

149 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2028-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Arthroscopy

Intervention Type PROCEDURE

Arthroscopic Surgery on the hip, shoulder, or knee

Arthroplasty

Intervention Type PROCEDURE

Total hip, shoulder, or knee 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

Arthroscopy

Intervention Type PROCEDURE

Arthroscopic Surgery on the hip, shoulder, or knee

Arthroplasty

Intervention Type PROCEDURE

Total hip, shoulder, or knee 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

Arthroscopy

Intervention Type PROCEDURE

Arthroscopic Surgery on the hip, shoulder, or knee

Arthroplasty

Intervention Type PROCEDURE

Total hip, shoulder, or knee arthroplasty

Interventions

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Arthroscopy

Arthroscopic Surgery on the hip, shoulder, or knee

Intervention Type PROCEDURE

Arthroplasty

Total hip, shoulder, or knee arthroplasty

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Adult patients ( \> 18 years old)
2. Patient is eligible for general anesthesia and either arthroscopy or arthroplasty.
3. Patient needs standard of care arthroscopy or arthroplasty of either shoulder, hip or knee joint for osteoarthritis or prearthritic conditions.
4. Patient must have signed an IRB approved informed consent document for the arthrocentesis procedure which will be performed during the arthroscopic or arthroplastic procedure.

Exclusion Criteria

1. Active Joint Infection within last 6 months.
2. Previous arthroplasty in the joint undergoing arthroplasty
3. History of auto-immune arthropathies.
4. History of HIV or Hepatitis C
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard C. Mather, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke Orthopaedic Clinics

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00066468

Identifier Type: -

Identifier Source: org_study_id

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