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Measuring Synovial Fluid Components

Primary Purpose

Knee Osteoarthritis

Status

Active

Phase

Not Applicable

Locations

Argentina

Study Type

Interventional

Intervention

Measuring synovial fluid components

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 artthritis
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..
Elevation of sed rate, C-reactive protein, rheumatoid fractor, or antinuclea antibody.

Sites / Locations

Dharma Centro de Medicina Regenerativa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

Dextrose injection

Hematopoietic stem cells

Platelet Rich Plasma injection

No injection

Arm Description

Injection of 10 ml of 12.5% dextrose

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)

Injection of 10 ml of leukocyte rich platelet rich plasma

Aspiration of synovial fluid may be an active comparator.

Outcomes

Primary Outcome Measures

Measurement of unspecified components of synovial fluid (Unspecified due to proprietary reasons)

Change in level of unspecified synovial fluid components from Day 0 to Day 14

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05416255

First Posted

June 5, 2022

Last Updated

July 26, 2022

Sponsor

Dharma Bioscience

1. Study Identification

Unique Protocol Identification Number

NCT05416255

Brief Title

Measuring Synovial Fluid Components

Official Title

Measuring Synovial Fluid Components

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 1, 2022 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dharma Bioscience

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dextrose injection

Arm Type

Active Comparator

Arm Description

Injection of 10 ml of 12.5% dextrose

Arm Title

Hematopoietic stem cells

Arm Type

Active Comparator

Arm Description

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)

Arm Title

Platelet Rich Plasma injection

Arm Type

Active Comparator

Arm Description

Injection of 10 ml of leukocyte rich platelet rich plasma

Arm Title

No injection

Arm Type

Active Comparator

Arm Description

Aspiration of synovial fluid may be an active comparator.

Intervention Type

Diagnostic Test

Intervention Name(s)

Measuring synovial fluid components

Intervention Description

Using speialized techniques to measure S.F. components

Primary Outcome Measure Information:

Title

Measurement of unspecified components of synovial fluid (Unspecified due to proprietary reasons)

Description

Change in level of unspecified synovial fluid components from Day 0 to Day 14

Time Frame

Day 0 to Day 14

Secondary Outcome Measure Information:

Title

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

Description

Change in WOMAC score from Day 0 to Day 14

Time Frame

Day 0 to Day 14

Other Pre-specified Outcome Measures:

Title

0-10 Numerical Rating Scale for pain (NRS) (11 point scale. Higher values are a worse outcome)

Description

Change in NRS pain score from Day 0 to Day 14

Time Frame

Day to Day 14

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 artthritis 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.. Elevation of sed rate, C-reactive protein, rheumatoid fractor, or antinuclea antibody.

Facility Information:

Facility Name

Dharma Centro de Medicina Regenerativa

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

2000

Country

Argentina

12. IPD Sharing Statement

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Measuring Synovial Fluid Components

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