Measuring Synovial Fluid Components

NCT05416255 | Unknown

• 1 other identifier: SFComponents#1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Western Ontario and McMaster Universities Arthritis Index (WOMAC) (0-100 scale) Higher scores are a worse outcome.

  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)

  Day to Day 14

Study Arms (4)

Dextrose injection

ACTIVE COMPARATOR

Injection of 10 ml of 12.5% dextrose

Diagnostic Test: Measuring synovial fluid components

Hematopoietic stem cells

ACTIVE COMPARATOR

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

Platelet Rich Plasma injection

ACTIVE COMPARATOR

Injection of 10 ml of leukocyte rich platelet rich plasma

Diagnostic Test: Measuring synovial fluid components

No injection

ACTIVE COMPARATOR

Aspiration of synovial fluid may be an active comparator.

Diagnostic Test: Measuring synovial fluid components

Interventions

Measuring synovial fluid components DIAGNOSTIC_TEST

Using speialized techniques to measure S.F. components

Dextrose injection; Hematopoietic stem cells; No injection; Platelet Rich Plasma injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dharma Bioscience: lead

Study Sites (1)

Dharma Centro de Medicina Regenerativa

Rosario, Santa Fe Province, 2000, Argentina

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Treating physician and primary investigator

Model Details: Consecutive patients treated for knee osteoathritis with dextrose injection, hemaopoietic stem cell injection, PRP injection, or no injection.

Study Record Dates

• First Submitted: June 5, 2022
• First Posted: June 13, 2022
• Study Start: April 1, 2022
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 30, 2024

Record last verified: 2023-09

Locations

AR (1)