Measuring Synovial Fluid Components

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: Active, not recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Diagnostic test: Measuring synovial fluid components

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

Study Locations

• Argentina
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Dharma Centro de Medicina Regenerativa

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dextrose injection; Injection of 10 ml of 12.5% dextrose	Diagnostic test: Measuring synovial fluid components; 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)	Diagnostic test: Measuring synovial fluid components; Using speialized techniques to measure S.F. components
Active Comparator: Platelet Rich Plasma injection; Injection of 10 ml of leukocyte rich platelet rich plasma	Diagnostic test: Measuring synovial fluid components; Using speialized techniques to measure S.F. components
Active Comparator: No injection; Aspiration of synovial fluid may be an active comparator.	Diagnostic test: Measuring synovial fluid components; 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	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.	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)	Change in NRS pain score from Day 0 to Day 14	Day to Day 14

Collaborators and Investigators

• Sponsor: Dharma Bioscience

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): December 31, 2024

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): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 27, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• 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