Acellular Matrix Homologous From Human Dermis in Combination With Orthobiologic Stimuli,Subacromial Bursa and Humeral Bone Marrow Concentrate, for Augmentation of Massiverotator Cuff Tears: Therapeutic Efficacy and Improvements for the Development of a Costeffective and Ready to Use Product
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- re-tear rate
研究概览
简要总结
The use of biologic acellular matrices for the surgical augmentation of rotator cuff lesions has greatly expanded inrecent years. The study team patented a method for removing cells from human dermis (Acellular Dermal Matrix), maintaining unaltered biological and structural integrity. Acellular Dermal Matrix has been succesfully used for rotator cuff surgical repair augmentation beside in a limited number of patients. The aim of the project is to demonstrate the therapeutical efficacy of this strategy in patients affected by rotator cuff massive tears. Acellular Dermal Matrix will be also combined with autologous orthobiologics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients affected by large to massive lesion according to Gerber involving supraspinatus and infraspinatus tendons
- •tendon retraction <=3 according to Thomazeau
- •fatty degeneration <=3 according to Goutallier
- •possibility to obtain tendon reduction,
- •pre-operative Magnetic Resonance Imaging,
- •ability to read, understand and complete outcome scores
排除标准
- •patients affected by osteoarthritic degeneration,
- •frozen shoulder,
- •symptomatic acromioclavicular arthritis,
- •revision surgeries,
- •inability to cope with post-operative rehabilitation regimen,
- •autoimmune connective tissue disease,
- •current or past hematologicaldisorders,
- •comorbidities affecting healing,
- •active infections,
- •pregnancy and lactation
研究组 & 干预措施
Acellular Dermal Matrix
Enrolled patients will be randomly assigned to the suture-bridge technique with acellular dermal matrix
干预措施: Acellular Dermal Matrix (Other)
Acellular Dermal Matrix with autologous orthobiologics
Enrolled patients will be randomly assigned to the suture-bridge technique with acellular dermal matrix with orthobiologics autologous: humeral bone marrow concentrate and subacromial bursa
干预措施: Acellular Dermal Matrix with autologous orthobiologics (Other)
结局指标
主要结局
re-tear rate
时间窗: 12 months after surgery
Presence/absence of re-tear on magnetic resonance imaging
次要结局
- cell yeld(baseline)
- subacromial bursa(baseline)