Arthroscopic Rotator Cuff Reconstruction With Xenologous Dermis-patch Augmentation and ACP® - Injection in Patients Over 60 Years (ACP = Autologous Conditioned Plasma)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Oxford Shoulder Score (Questionnaire)
研究概览
简要总结
The purpose of this study is to show that an augmentation with the DX Reinforcement Matrix from Arthrex is possible with the arthroscopic technique.
详细描述
The shoulder joint, specially the rotator cuff, is one of the most complicated joints of the human body. If the tendon has to be fixed at the bone during surgery, the weak point in obtaining a successful surgery is the fixation of the tendon at the bone insertion site. Tendon belongs to the bradytrophic tissue conditional on the reduced blood flow, deep mitosis rate and lowered healing potential.
The patients in this study have 60 years or more. The tissue of these patients isn't as good as in young patients. The patch will be used to improve the strength of the tendon at the insertion site and the ingrowth process of the new tissue at this area. Additionally the investigators can boost the healing process with a selective use of PRP (PRP = platelet rich plasma). In this process, the healing site is delivered with an elevated concentration of thrombocytes and also growth factors which are constituent parts of them.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Arthroscopic rotator cuff reconstructions of degenerative or traumatic full thickness rotatorcuff tears (supraspinatus should be affected)performed by Dr. Flury
- •Age: 60 years or more
- •Suture bridge technique
- •Women: No longer of childbearing age (at menopause and last menstrual period more than 12 months, prevented surgically Ovaries and/or uterus removed surgically)
- •Signed consent form
排除标准
- •Partial reconstruction of the rotator cuff (PASTA)
- •Open reconstruction
- •Tendon transfer (latissimus dorsi or pectoralis major)
- •Revision surgery
- •Omarthrosis (Level ≥ 2 Samilson & Prieto)
- •Systemic arthritis
- •Rheumatoid arthritis
- •Diabetes (insulin treated)
- •Requiring surgery in reconstruction of the subscapularis tendon
- •Progressive fat inclusion (fatty infiltration of the rotator cuff musculature goutallier level IV
- •Acute or chronic infection
- •Pathological bone metabolism
- •Insufficient perfusion in the affected arm
- •Neuromuscular disease in the affected arm
- •Non compliance of the patient
- •Disorders which handicap or inhibit the patient to follow the orders of the clinical testers
结局指标
主要结局
Oxford Shoulder Score (Questionnaire)
时间窗: 3mo
The Oxford Shoulder Score used after 3 months is the primary parameter. The Score tests the ability to participate in the patients' normal life before they got injured.
次要结局
- ROM (degrees)(3/6/24mo)
- Measurement of the abduction strength (Kilograms)(3/6/24 mo)
- MRI/X-Ray/Ultrasonic Diagnostics (Objective Evaluation (Descriptive) of the healing process)(6/24 mo)
- QuickDASH Questionnaire (Short version of Disability of the Arm, Shoulder and Hand Questionnaire)(3/6/24mo)
- Oxford Shoulder Score (Questionnaire)(6mo/24mo)
- Measurement of the external rotation strength (Kilograms)(3/6/24 mo)
- VAS Pain Scoring Tool(10d)
- EQ-5D Questionnaire(3/6/24 mo)
- ASES Score (American Shoulder And Elbow Surgeons Questionnaire)(3/6/24mo)
- Constant Murley Score (CMS)(3/6/24 mo)
研究者
Matthias Flury
Principal Investigator (Department of Upper Extremity)
Schulthess Klinik