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

Meniscal Tear Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03059706
• Other study ID #: PROC-3
• Status: Recruiting
• Phase: N/A
• First received: February 7, 2017
• Last updated: August 22, 2017
• Start date: March 23, 2017
• Est. completion date: May 2018

Study information

• Verified date: August 2017
• Source: Kaplan Medical Center
• Contact: Philip Rosinsky
• Phone: 0508990006
• Email: prosinsky[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Meniscal Tear

Intervention

Device:
• RegenoGel-OSP™
intra-articular injection of RegenoGel-OSP™ after arthroscopic surgery

Other:
• saline
intra-articular injection of saline after arthroscopic surgery

Locations

Country	Name	City	State
Israel	Kaplan Medical Center	Re?ovot

Sponsors (2)

Lead Sponsor	Collaborator
Kaplan Medical Center	ProCore Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	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	Incidence of treatment-emergent adverse events.	Self reported adverse events	self-reported adverse events will be evaluated for 6 months follow-up.
Secondary	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.
Secondary	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