The Effect of Intra-Articular Injection of RegenoGel-OSP™(Self-Plasma) to Treat Pain Following Arthroscopic Surgery
NCT ID: NCT03059706
Last Updated: 2017-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
36 participants
INTERVENTIONAL
2017-03-23
2018-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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RegenoGel-OSP™
RegenoGel-OSP™
intra-articular injection of RegenoGel-OSP™ after arthroscopic surgery
Placebo
saline
intra-articular injection of saline after arthroscopic surgery
Interventions
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RegenoGel-OSP™
intra-articular injection of RegenoGel-OSP™ after arthroscopic surgery
saline
intra-articular injection of saline after arthroscopic surgery
Eligibility Criteria
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Inclusion Criteria
* 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 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).
45 Years
ALL
No
Sponsors
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ProCore Ltd.
INDUSTRY
Kaplan Medical Center
OTHER
Responsible Party
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Philip Rosinsky
Resident in Orthopedic Surgery Department
Locations
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Kaplan Medical Center
Rehovot, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PROC-3
Identifier Type: -
Identifier Source: org_study_id
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