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

Kaplan Medical Center

Status

Unknown

Conditions

Meniscal Tear

Treatments

Other: saline

Device: RegenoGel-OSP™

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03059706

PROC-3

Details and patient eligibility

About

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.

Enrollment

36 estimated patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

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).