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

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

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.

Study Overview

• Status: Unknown
• Conditions: Meniscal Tear
• Intervention / Treatment: Device: RegenoGel-OSP™; Other: saline

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philip Rosinsky; Phone Number: 0508990006; Email: prosinsky@gmail.com

Study Locations

• Israel
  • Reẖovot, Israel, 76100
    • Recruiting
    • Kaplan Medical Center
    • Contact: Philip Rosinsky, MD; Phone Number: 0508990006; Email: prosinsky@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kaplan Medical Center
• Collaborators: ProCore Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2017
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: February 7, 2017
• First Submitted That Met QC Criteria: February 16, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): August 23, 2017
• Last Update Submitted That Met QC Criteria: August 22, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: PROC-3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No