The Effect of Intra-Articular Injection of RegenoGel-OSP™(Self-Plasma) to Treat Pain Following Arthroscopic Surgery

Study Overview
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Brief Summary
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This study evaluates the efficacy of intra-articular administration of RegenoGel-OSP™ 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-OSP™ or placebo treatment on a 1:1 basis.

Official Title
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Randomized, Open-Labal, Placebo-Controlled Trial of the Effect of Intra-Articular Injection of RegenoGel-OSP™ (Slef-Plasma) to Treat Pain Following Arthroscopic Surgery

Conditions
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Meniscal Tear

Intervention / Treatment
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* Device: RegenoGel-OSP™
* Other: saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has signed and dated the informed consent form. Subject is a male or female over the age of 45. Patients scheduled for knee arthroscopic surgery due to degenerative or traumatic meniscal tear. Exclusion Criteria: Subject had any intra-articular injections to the intended study knee within 3 months prior to Screening. Subject is unable to stop chronic administration of pain medications (including paracetamol), from the day before each study visit through completion of the study visit. Subject has a history of Psoriatic Arthritis, Rheumatoid Arthritis,or any other inflammatory condition associated with arthritis. Subject has a superficial wound in the area of the intended study knee. Subject is scheduled for knee ligaments reconstructive surgery. Subject has fever signs or symptoms of systemic infection or infection of the intended study knee. Subject has known sensitivity to any of the treatment components, egg, rubber or latex. Subject has a history of anaphylactic shock or other severe systemic response or other adverse event to human blood products. Subject has a clinically significant abnormal finding (e.g., laboratory result or ECG). Subject has known Human Immunodeficiency Virus / Acquired Immunodeficiency Syndrome (HIV/AIDS), Hepatitis B or C viral infections, or acute or chronic liver disease. Subject has ever had cellulitis of the lower extremities, a superficial or deep vein thrombosis, or a family history of a clotting disorders. Subject receives any investigational device or product within 30 days of Visit l. Subject is receiving an oral or injected anticoagulant. Subject ever abused drugs or alcohol (self-reported).

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RegenoGel-OSP™<br> | Device: RegenoGel-OSP™<br>* intra-articular injection of RegenoGel-OSP™ after arthroscopic surgery<br>|
| Placebo Comparator: Placebo<br> | Other: saline<br>* intra-articular injection of saline after arthroscopic surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |