Evaluation of Biomarkers in Human Synovial Fluid

NCT02664870 | Active Not Recruiting

• 1 other identifier: Pro00066468
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

synovial fluid; biomarkers

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (4)

• Number of biomarkers worthy of study to aid in the diagnosis and progression of osteoarthritis

  3-5 years

• Types of biomarkers worthy of study to aid in the diagnosis and progression of osteoarthritis

  3-5 years

• Number of patients who responded to non-arthroplasty intervention based on biomarker analysis and measured with questionnaires

  1-10 years

• Number of patients who did not respond to non-arthroplasty intervention based on biomarker analysis and measured with questionnaires

  1-10 years

Study Arms (3)

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

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

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

Procedure: Arthroscopy; Procedure: Arthroplasty

Interventions

Arthroscopy PROCEDURE

Arthroscopic Surgery on the hip, shoulder, or knee

Hip Patients; Knee Patients; Shoulder Patients

Arthroplasty PROCEDURE

Total hip, shoulder, or knee arthroplasty

Hip Patients; Knee Patients; Shoulder Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited at the Sports Medicine and Adult Reconstruction Clinics at Duke University Medical Center.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Orthopaedic Clinics

Durham, North Carolina, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biospecimen retention would include the collection and storage of synovial fluid samples from the hip, shoulder, and knee.

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroscopy; Arthroplasty

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Orthopedic Procedures; Plastic Surgery Procedures

Study Officials

• Richard C. Mather, MD, MBA

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2016
• First Posted: January 27, 2016
• Study Start: January 1, 2016
• Primary Completion: January 24, 2019
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

US (1)