Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dextrose injection | Active Comparator | Injection of 10 ml of 12.5% dextrose |
|
| 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) |
|
| Platelet Rich Plasma injection | Active Comparator | Injection of 10 ml of leukocyte rich platelet rich plasma |
|
| No injection | Active Comparator | Aspiration of synovial fluid may be an active comparator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measuring synovial fluid components | Diagnostic Test | Using speialized techniques to measure S.F. components |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:≥ 6 months of knee pain with walking
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dharma Centro de Medicina Regenerativa | Rosario | Santa Fe Province | 2000 | Argentina |
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Consecutive patients treated for knee osteoathritis with dextrose injection, hemaopoietic stem cell injection, PRP injection, or no injection.
Not provided
Not provided
Not provided
Not provided
| D012216 |
| Rheumatic Diseases |