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To compare the efficacy and structural change of intraarticular single platelet-rich plasma(PRP) versus novel crosslinked Hyaluronic Acid(HA)(HyajointPlus) for the treatment of early stage knee osteoarthritis(OA). This was a prospective, double-blind, RCT with an allocation ratio of 1:1.
In the PRP group, an Aeon Acti-PRP set was used and an approximately 4-mL PRP volume was yielded and was used in a single-dose treatment. In the HA group, HYAJOINT Plus containing 60 mg of purified sodium hyaluronate was used in a single-dose treatment. All PRP and HA injection syringes were covered with opaque envelop, and the intra-articular injection procedure was performed by the same physician without ultrasound or other imaging guidance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet Rich Plasma group | Experimental | single injection platelet rich plasma |
|
| Hyaluronic Acid group | Experimental | single injection of hyaluronic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet Rich Plasma | Combination Product | In the Platelet Rich Plasma group, 4mL Platelet Rich Plasma was given. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change of Western Ontario and McMaster Universities Index (WOMAC) score from baseline | The minimum value of Western Ontario and McMaster Universities Index (WOMAC) score is zero and the maximum is 96, whether higher scores mean a worse outcome. | Baseline and 1-month, 3-month, 6-month after injection |
| Measure | Description | Time Frame |
|---|---|---|
| The change of Knee Cartilage Grading System from baseline | The Cartilage Grading System classifies the cartilage from grades 0 to 6 according to parameters of sharpness, clarity and thickness change of the cartilage band. Grade 0 refers to normal and healthy cartilage, while grade 6 refers to severely eroded cartilage, whether higher scores mean a worse outcome. | Baseline and 1-month, 3-month, 6-month after injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hsuan-Ti Huang, M.D | Kaohsiung Medical University, Orthopedics Department | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Medical University Hospital | Kaohsiung City | 807 | Taiwan |
all IPD that underlie results in a publication
starting 12 months after publication
Studies involving platelet rich plasma, hyaluronic acid can contact us for additional information.
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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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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Hyaluronic Acid | Combination Product | In the Hyaluronic group, 3mLHYAJOINT Plus was given. |
|
| The change of Knee Cartilage strain ratio from baseline | The strain represents the elasticity. We used the overlying soft tissue as reference. Larger strain ratio means the cartilage is softer, while smaller strain ratio means the cartilage is harder. | Baseline and 1-month, 3-month, 6-month after injection |
| The change of MRI Osteoarthritis Knee Score (MOAKS) from baseline | Fourteen subregions are defined for scoring of articular cartilage and bone marrow lesions in cluding patella, femur and tibia region. Grade 0 refers to normal and healthy cartilage without loss, while grade 3 refers >75% cartilage full thickness loss, whether higher scores mean a worse outcome. | Baseline and 6-month after injection |
| D012216 |
| Rheumatic Diseases |