Randomized, Open-Labal, Placebo-Controlled Trial of the Effect of Intra-Articular Injection of RegenoGel-OSP™ (Slef-Plasma) to Treat Pain Following Arthroscopic Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Efficacy of RegenoGel-OSP to treat pain following arthroscopic surgery
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has signed and dated the informed consent form.
- •Subject is a male or female over the age of
- •Patients scheduled for knee arthroscopic surgery due to degenerative or traumatic meniscal tear.
排除标准
- •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).
研究组 & 干预措施
RegenoGel-OSP™
干预措施: RegenoGel-OSP™ (Device)
Placebo
干预措施: saline (Other)
结局指标
主要结局
Efficacy of RegenoGel-OSP to treat pain following arthroscopic surgery
时间窗: The questionnaires will filled for 6 months after surgery
The subjects will answer VAS (Visual Analog Score) questionnaire for grading of their pain level
Efficacy of RegenoGel-OSP on function following arthroscopic surgery
时间窗: Change from baseline at 6 months after surgery.
Radiograph of the terget knee will be obtained.
Efficacy of RegenoGel-OSP on function following arthroscopic surgery
时间窗: The questionnaires will filled for 6 months after surgery.
The subjects will answer three questionnaires for grading of their symptoms and overall functional performance
次要结局
- Incidence of treatment-emergent 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 questionnaires will be filled for 6 months follow-up after surgery.)
- Incidence, relatedness and severity of treatment-emergent adverse events.(Physical examination will be evaluated for 6 months follow-up)
研究者
Philip Rosinsky
Resident in Orthopedic Surgery Department
Kaplan Medical Center