Measuring Synovial Fluid Components

Knee Osteoarthritis Clinical Trial

Official title:

Measuring Synovial Fluid Components

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05416255
• Other study ID #: SFComponents#1
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Dharma Bioscience
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Diagnostic Test:
• Measuring synovial fluid components
Using speialized techniques to measure S.F. components

Locations

Country	Name	City	State
Argentina	Dharma Centro de Medicina Regenerativa	Rosario	Santa Fe

Sponsors (1)

Lead Sponsor	Collaborator
Dharma Bioscience

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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