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The study consists of 3 phases (enrollment, infiltrative procedure, and controls):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| infiltrative procedure | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRP infiltration | Procedure | a single intra-articular infiltration of 5 mL of PRP-O will be performed by the infiltrating physician. It is specified that the PRP-O used within the study will be produced following the guidelines and standards for the production of blood products for non-transfusion use as already in place at the Unified Metropolitan Transfusion Service IOR site. PRP (Platelet Rich Plasma) is produced from platelet pool from donor buffy coat. PRP contains 1,000,000 PLT/mml +/- 20%, as required by current regulations. |
| Measure | Description | Time Frame |
|---|---|---|
| International Knee Documentation Committee score | This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathology. The questionnaire examines 3 categories: symptoms, sports activity, and knee function. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| International Knee Documentation Committee score | This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathology. The questionnaire examines 3 categories: symptoms, sports activity, and knee function. | baseline, 1, 3, 6, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability assessment parameters: | All adverse events will be reported by filling out "Adverse event report forms" that will be kept with each patient's CRF (Case Report Form). The latter will document all medications taken additionally by the patient for pain control, indicating brand name, generic name, start and end of intake, and daily dose. Serious adverse events will be reported as per company procedure and the Ethics Committee will be informed, which will rule on whether patient enrollment should be discontinued. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mirco Lo Presti, MD | Contact | 0516366 | 084 | mirco.lopresti@ior.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS - Istituto ortopedico Rizzoli | Recruiting | Bologna | 40136 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16921694 | Result | Everts PA, Knape JT, Weibrich G, Schonberger JP, Hoffmann J, Overdevest EP, Box HA, van Zundert A. Platelet-rich plasma and platelet gel: a review. J Extra Corpor Technol. 2006 Jun;38(2):174-87. | |
| 12608674 | Result | Sanchez AR, Sheridan PJ, Kupp LI. Is platelet-rich plasma the perfect enhancement factor? A current review. Int J Oral Maxillofac Implants. 2003 Jan-Feb;18(1):93-103. |
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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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|
| Tegner Activity Level Scale |
It is a questionnaire to find out the patient's level of physical activity |
| baseline, 1, 3, 6, 12 months |
| Knee Injury and Osteoarthritis Outcome Score | The full questionnaire consists of five subscales and they cover: pain (9 items), symptoms (7 items of which two relate to stiffness), functions and activities of daily living (17 items) physical function, sports activities and leisure (5 items) and quality of life in relation to the knee (4 items). All items in the relevant subscales have the same response mode, use a 5-point Likert scale, and each question is assigned a score from 0 to 4, where 0 indicates "no difficulty" and 4 "a severe difficulty). Score range 0-100 for each subscale. | baseline, 1, 3, 6, 12 months |
| Visual Analogue Scale | visual analog scale consisting of a straight line segment (10 cm length), the ends of which correspond to "no pain" and "the strongest pain imaginable" | baseline, 1, 3, 6, 12 months |
| objective parameter | range of motion and bilateral trans patellar and supra patellar circumferences for comparative analysis. | baseline, 1, 3, 6, 12 months |
| Patient Acceptable Symptom State | Valuable tool for assessing patient satisfaction considering the patient's current degree of pain, function, and daily activity. | baseline, 1, 3, 6, 12 months |
| Expectations of treatment efficacy | The patient should indicate at baseline what benefits he or she expects from the treatment. | baseline |
| Overall judgment on treatment | The patient should indicate the degree of satisfaction related to the treatment performed at each follow-up. | baseline, 1, 3, 6, 12 months |
| baseline, 1, 3, 6, 12 months |
| Platelet-rich plasma-Homologous (PRP-O) evaluation parameters | The quality of the administered Platelet-rich plasma- Homologous (PRP-O) will be assested by using standard blood parameters data as hematological control. | baseline, 1, 3, 6, 12 months |
| D012216 |
| Rheumatic Diseases |