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| Name | Class |
|---|---|
| ProCore Ltd. | INDUSTRY |
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This study evaluates the efficacy of intra-articular administration of RegenoGel-OSPâ„¢ to treat pain and the safety and efficacy on subject's activity and quality of life following arthroscopic surgery due to degenerative or traumatic meniscal tear. adult subjects will be randomized and sequentially assigned to RegenoGel-OSPâ„¢ or placebo treatment on a 1:1 basis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RegenoGel-OSPâ„¢ | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RegenoGel-OSPâ„¢ | Device | intra-articular injection of RegenoGel-OSPâ„¢ after arthroscopic surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of RegenoGel-OSP to treat pain following arthroscopic surgery | The subjects will answer VAS (Visual Analog Score) questionnaire for grading of their pain level | The questionnaires will filled for 6 months after surgery |
| Efficacy of RegenoGel-OSP on function following arthroscopic surgery | The subjects will answer three questionnaires for grading of their symptoms and overall functional performance | The questionnaires will filled for 6 months after surgery. |
| Efficacy of RegenoGel-OSP on function following arthroscopic surgery | Radiograph of the terget knee will be obtained. | Change from baseline at 6 months after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events. | Self reported adverse events | self-reported adverse events will be evaluated for 6 months follow-up. |
| The efficacy of RegenoGel-OSP on subject's activity and quality of life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philip Rosinsky | Contact | 0508990006 | prosinsky@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaplan Medical Center | Recruiting | Rehovot | 76100 | Israel |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| saline | Other | intra-articular injection of saline after arthroscopic surgery |
|
The subjects will answer four questionnaires for grading of their symptoms, pain level and overall functional performance.
| The questionnaires will be filled for 6 months follow-up after surgery. |
| Incidence, relatedness and severity of treatment-emergent adverse events. | physical examination of the study knee by the investigator. | Physical examination will be evaluated for 6 months follow-up |
| D017670 |
| Sodium Compounds |