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The purpose of this study is to demonstrate that platelet-derived repairing factors are effective and safe in the treatment of muscular lesion grade 2 or 3, a Phase II, open-label, single arm, single centre has been designed. Sample size will be 25.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet-derived repairing factors | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| platelet-derived repairing factors | Biological | autologous platelet lysate injection within 24 hours from lesion |
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| Measure | Description | Time Frame |
|---|---|---|
| number (and proportion with 95% CI) of patients able to return to sport activity (i.e. training) at 21 days from muscular injury. | If the athlete is able, 21 days after the muscular injury, to return to (at least) training activities, the outcome will be coded "successful"; and "unsuccessful" otherwise | 21 days from enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-return to sport activities | within 4 months from lesion | |
| Side effects | Overall frequency of patients with any adverse events (number, proportion and 95%CI) | within 4 months from treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Ortopedica Fondazione IRCCS Policlinico San Matteo | Pavia | 27100 | Italy |
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| time-to-healing at ultrasound | within 4 months from treatment |
| side effects | types of side effects (number, proportion and 95%CI for each type of adverse events) | within 4 months from treatment |
| side effects | grade of side effects (number, proportion and 95%CI for each grade of adverse events) | within 4 months from treatment |