Measuring Synovial Fluid Components

Not Applicable

Active, not recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Diagnostic Test: Measuring synovial fluid components

• Registration Number: NCT05416255
• Lead Sponsor: Dharma Bioscience

Brief Summary

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.

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 Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2022-06-05
• Study First Submitted QC: 2022-06-08
• Study First Posted: 2022-06-13
• Status Verified: 2023-09
• Last Update Submitted: 2024-04-27
• Last Update Posted: 2024-04-30
• Primary Completion: 2024-08-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hematopoietic stem cells	Measuring synovial fluid components	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)
Platelet Rich Plasma injection	Measuring synovial fluid components	Injection of 10 ml of leukocyte rich platelet rich plasma
No injection	Measuring synovial fluid components	Aspiration of synovial fluid may be an active comparator.
Dextrose injection	Measuring synovial fluid components	Injection of 10 ml of 12.5% dextrose

Primary Outcome Measures

Name	Time	Method
Cytokine and unspecified component levels in synovial fluid	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

Secondary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities Arthritis Index (WOMAC) (0-100 scale) Higher scores are a worse outcome.	Day 0 to Day 14	Change in WOMAC score from Day 0 to Day 14

Trial Locations

Locations (1)

Dharma Centro de Medicina Regenerativa; 🇦🇷 Rosario, Santa Fe, Argentina