Clinical trial NCT03059706: The Effect of Intra-Articular Injection of RegenoGel-OSP™(Self-Plasma) to Treat Pain Following Arthroscopic Surgery
Official title: Randomized, Open-Labal, Placebo-Controlled Trial of the Effect of Intra-Articular Injection of RegenoGel-OSP™ (Slef-Plasma) to Treat Pain Following Arthroscopic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Meniscal Tear
Lead sponsor: Kaplan Medical Center
Sponsor class: OTHER
Collaborators: name: ProCore Ltd.
First posted: 2017-02-23
Enrollment: 36
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Efficacy of RegenoGel-OSP to treat pain following arthroscopic surgery
timeFrame: The questionnaires will filled for 6 months after surgery
measure: Efficacy of RegenoGel-OSP on function following arthroscopic surgery
timeFrame: The questionnaires will filled for 6 months after surgery.
measure: Efficacy of RegenoGel-OSP on function following arthroscopic surgery
timeFrame: Change from baseline at 6 months after surgery.
Secondary outcomes:
measure: Incidence of treatment-emergent adverse events.
timeFrame: self-reported adverse events will be evaluated for 6 months follow-up.
measure: The efficacy of RegenoGel-OSP on subject's activity and quality of life.
timeFrame: The questionnaires will be filled for 6 months follow-up after surgery.
measure: Incidence, relatedness and severity of treatment-emergent adverse events.
timeFrame: Physical examination will be evaluated for 6 months follow-up
Other outcomes:
Locations:
city: Reẖovot
country: Israel
facility: Kaplan Medical Center
Study officials:
References: