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This monocentric protocol is designed to evaluate the efficacy of therapeutic management of symptomatic knee osteoarthritis (resistant to medical first-line treatment) by intra-articular injection of autologous PRP prepared in the same procedure and using a dedicated CE marked medical device and a validated and reproducible method of preparation
The main objective is to get a 50% proportion of responders defined by answers "absent" or "light" in the KOOS questionnaire on questions about pain and difficulty walking on flat ground.
Secondary objectives include the safety validation of the use of PRP (prepared standardized manner by means of a given medical device) as second-line standard of care for osteoarthritis by the introduction of a systematic monitoring; and the feasibility of the health care system dedicated to the treatment of knee osteoarthritis by autologous PRP.
Furthermore, the secondary objectives are to monitor and follow the evolution of pain (VAS) and the knee function (KOOS score) at 1 month, 3 months, 6 months. Evaluation of MRI will be performed within 15 days prior (inclusion visit) injection and 6 months to assess the cartilage thickness and visualize a regenerative effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| knee osteoarthritis patients. | Other | therapeutic management of symptomatic knee osteoarthritis (resistant to medical first-line treatment) by intra-articular injection of autologous PRP prepared in the same procedure and using a dedicated CE marked medical device and a validated and reproducible method of preparation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous PRP. | Biological | one autologous PRP patient in this study and monitor and follow the evolution of pain and the knee function |
|
| Measure | Description | Time Frame |
|---|---|---|
| to monitor and follow the evolution of pain | VAS to monitor and follow the evolution of pain | prior,1 month, 3 months, 6 months |
| to monitor and follow the evolution of the knee function | (KOOS score) | prior,1 month, 3 months, 6 months |
| Evaluation of MRI | Evaluation will be performed within 15 days prior (inclusion visit) injection and 6 months to assess the cartilage thickness and visualize a regenerative effect. | prior,1 month, 3 months, 6 months |
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Inclusion Criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Saint Joseph | Marseille | 13008 | France |
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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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descriptive study
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study for knee osteoarthritis patients treated in the center
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| D012216 |
| Rheumatic Diseases |