Measuring Synovial Fluid Components
August 26, 2026 updated by: Gastón Andres Topol, Dharma Bioscience
Participants with grade 3 and 4 knee osteoarthritis will recieve aspiration of synoivial fluid, and then receive either dextrose, hemaotopoietic stem cell, or platelet rich plasma, or no injection.
The synovial fluid will be analyzed for changes in components.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
80 participants with grade 3 and 4 symptomatic knee osteoarthritis, with a visable effusion, will receive aspiration of 3 ml of synovial fluid from the suprapatellar pouch, followed by either injection with 10 mL of 12.5% dextrose, 10 cc hematopoietic stem cells, 10cc PRP, or no injection into the suprapatellar pouch.
They will then receive aspiration of 3 ml of synovial fluid at 2 days and either 7 days (for dextrose injected or no injection) or 14 days (stem cell and PRP injected) days post injection.
These synovial samples will be analyzed for a change in components.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Santa Fe Province
-
Rosario, Santa Fe Province, Argentina, 2000
- Dharma Centro de Medicina Regenerativa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:≥ 6 months of knee pain with walking
- ≥ 6/10 on a 0-10 point numerical rating scale
- High grade medial compartment cartilage loss ( Kellgren-Lawrence grade 3 or 4) on plain weight bearing X-ray
- Exposed subchondral bone at 110 degrees of flexion by ultrasound examination
- Easily visible suprapatellar pouch with quads conttraction.
Exclusion Criteria
- Current intake of NSAIDs or steroids
- Current anticoagulation therapy
- Inflammatory or post-infectious knee arthritis
- Systemic inflammatory conditions
- Knee flexion less than 100 degrees
- Knee extension less than 165 degrees
- Valgus or varus more than 15 degrees
- Any knee injection in the precedign 3 months
- BMI more than 50 kg/ meter squared
- Gross synovial folds on ultrasound.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Dextrose injection
Injection of 10 ml of 12.5% dextrose
|
Using speialized techniques to measure S.F. components
|
|
Active Comparator: Hematopoietic stem cells
Injection of 10 ml of of 7.5 ml hematopoietic stem cells, 2 ml of 25% dextrose (5% diluted), 0.5 ml of 1% lidocaine (0.05% diluted),and 0.25 ml dexamethasone (1.5 mg)
|
Using speialized techniques to measure S.F. components
|
|
Active Comparator: Platelet Rich Plasma injection
Injection of 10 ml of leukocyte rich platelet rich plasma
|
Using speialized techniques to measure S.F. components
|
|
Active Comparator: No injection
Aspiration of synovial fluid may be an active comparator.
|
Using speialized techniques to measure S.F. components
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cytokine and unspecified component levels in synovial fluid
Time Frame: Day 0 to Day 14
|
Change in level of unspecified synovial fluid components from Day 0 to 7 or Day 0 to 14, depending on group
|
Day 0 to Day 14
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Western Ontario and McMaster Universities Arthritis Index (WOMAC) (0-100 scale) Higher scores are a worse outcome.
Time Frame: Day 0 to Day 14
|
Change in WOMAC score from Day 0 to Day 14
|
Day 0 to Day 14
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
0-10 Numerical Rating Scale for pain (NRS) (11 point scale. Higher values are a worse outcome)
Time Frame: Day to Day 14
|
Change in NRS pain score from Day 0 to Day 14
|
Day to Day 14
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 19, 2022
Primary Completion (Actual)
April 20, 2026
Study Completion (Actual)
April 20, 2026
Study Registration Dates
First Submitted
June 5, 2022
First Submitted That Met QC Criteria
June 8, 2022
First Posted (Actual)
June 13, 2022
Study Record Updates
Last Update Posted (Actual)
August 28, 2026
Last Update Submitted That Met QC Criteria
August 26, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SFComponents#1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.