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This study is aimed at evaluating the efficacy and safety of Cytorich compared to platelet-rich plasma (PRP) in alleviating pain and improving function in subjects with knee OA.
This active-controlled, randomized, double-blind, prospective study will enroll subjects with knee OA. Subjects will be randomized equally to treatment with 4 injections of ABP (test treatment) or 4 injections of PRP (active control).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABP | Experimental | (test treatment) |
|
| PRP | Active Comparator | (active control) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytorich PRP kit | Device | Subjects randomized to the PRP treatment arm will receive PRP only without the anti-inflammatory component of ABP added |
|
| Measure | Description | Time Frame |
|---|---|---|
| VAS pain score | Change in VAS pain score | Week 12 (Day 85) compared to baseline for ABP and PRP |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC pain and function score | Change in WOMAC pain and function score | Week 12 (Day 85) compared to baseline for ABP and PRP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ira Brokhman, PhD | Galea Clinic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galea Clinic | Etobicoke | Ontario | M8W 3T4 | Canada |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| PRP kit | Device | PRP kit legally marketed in Canada for PRP |
|
| D012216 |
| Rheumatic Diseases |