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OpenTrials
Completed

NCT Number: NCT05416255

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dharma Centro de Medicina Regenerativa

Rosario, Santa Fe Province, 2000, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Measuring synovial fluid components

Diagnostic Test

Using speialized techniques to measure S.F. components

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Dharma Bioscience

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 13, 2022
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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