A Prospective, Open Label, Single Arm, Multi-center Study to Assess the Safety and Performance of a Soft Tissue Repair Device (VergenixTM STR) in Patients With Epicondylitis (Tennis Elbow)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Collplant
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Tendon thickness (i.e tendon healing/improvement) and Doppler activity using US at 3M.
研究概览
简要总结
The VergenixTM STR device is intended for the repair of non ruptured tendon injuries (Tendinopathy).
详细描述
The VergenixTM STR device is an advanced Soft tissue repair device, made of lyophilized Type I rhCollagen and Calcium Chloride that will be mixed with autologous PRP prior to injection for the repair of non ruptured tendon injuries (Tendinopathy). Three (3) ml of the mixed solution will be injected into the common extensor tendon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Man or woman aged 18 - 80 years old.
- •Clinical diagnosis of lateral epicondylitis based on site of pain, pain
- •elicited with active extension of the wrist in pronation and elbow
- •Documented ultrasonography diagnosis of common extensor
- •tendinosis and possible tear based on abnormal echotexture (tendon
- •thickening, anechoic areas, areas of hypoechogencicity, loss of
- •fibrillar pattern).
- •Chronic symptoms (equal or greater than 3 months).
- •PRTEE questionnaire score of at least 50 out of
- •For child-bearing potential females, documentation of birth
- •Signing informed consent form. -
排除标准
- •Acute symptom onset (less than 3 months).
- •History of acute elbow trauma.
- •History of Rheumatoid Arthritis.
- •History of Inflammatory disease
- •History of Fibromyalgia
- •The patient has active malignant disease of any kind. A patient who
- •has had a malignant disease in the past, was treated and is currently
- •disease-free for at least 5 years, may be considered for study entry.
- •The patient is treated with anti-coagulant medication
- •The patient previously underwent a surgery for lateral
- •epicondylitis.
- •The patient previously received local injections, including steroids
- •within the last 30 days
- •Signs of other causes for lateral elbow pain (posterior interosseous
- •nerve entrapment, osteochondral lesion).
- •Wounds around the elbow
- •Likely problems, in the judgment of the investigator, with maintaining follow-up.
- •Clinically significant abnormalities in hematology and blood
- •chemistry lab tests at screening that in the opinion of the
- •investigator might interfere with the patient's safety or participation
- •in the study.
- •Known as positive HIV, hepatitis B, or hepatitis C.
- •Known history of a significant medical disorder, which in the
- •investigator's judgment contraindicates the patient's participation.
- •Known hypersensitivity and/or allergy to collagen.
- •Drug or alcohol abuse (by history).
- •Pregnancy of child-bearing potential females.
- •Participation in another study within 30 days prior to screening
研究组 & 干预措施
Arm 1 Tissue Repair Device
Tissue Repair Device
干预措施: Tissue Repair Device (VergenixTM STR) (Device)
结局指标
主要结局
Tendon thickness (i.e tendon healing/improvement) and Doppler activity using US at 3M.
时间窗: Up to 194 days
Functional Disability using the PRTEE questionnaire.
时间窗: Up to 194 days
Health related Quality of life parameters questionnaire.
时间窗: Up to 194 days
Pain free/maximum grip strength (Dynamometer)
时间窗: Up to 194 days
Changes in pain as a continuous outcome measure using the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire.
时间窗: Up to 194 days
次要结局
未报告次要终点