Measuring Synovial Fluid Components

NCT ID: NCT05416255

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2024-12-31

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dextrose injection

Injection of 10 ml of 12.5% dextrose

Group Type: ACTIVE_COMPARATOR

Measuring synovial fluid components

Intervention Type: DIAGNOSTIC_TEST

Using speialized techniques to measure S.F. components

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)

Group Type: ACTIVE_COMPARATOR

Measuring synovial fluid components

Intervention Type: DIAGNOSTIC_TEST

Using speialized techniques to measure S.F. components

Platelet Rich Plasma injection

Injection of 10 ml of leukocyte rich platelet rich plasma

Group Type: ACTIVE_COMPARATOR

Measuring synovial fluid components

Intervention Type: DIAGNOSTIC_TEST

Using speialized techniques to measure S.F. components

No injection

Aspiration of synovial fluid may be an active comparator.

Group Type: ACTIVE_COMPARATOR

Measuring synovial fluid components

Intervention Type: DIAGNOSTIC_TEST

Using speialized techniques to measure S.F. components

Interventions

Measuring synovial fluid components

Using speialized techniques to measure S.F. components

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• ≥ 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dharma Bioscience

OTHER

Sponsor Role: lead

Responsible Party

Gastón Andres Topol

Treating physician and primary investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dharma Centro de Medicina Regenerativa

Rosario, Santa Fe Province, Argentina

Countries

Argentina

Other Identifiers

SFComponents#1

Identifier Type: -

Identifier Source: org_study_id