Evaluation of Tendon-to-Bone Healing Potential in Arthroscopic Rotator Cuff Repair Through Biological Stimulation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Retear rate
研究概览
简要总结
Evaluation of clinical and radiological outcomes in patients undergoing Arthroscopic Rotator Cuff Repair with standard treatment compared to patients receiving biological stimulation with micro-perforations or with the combination of micro-perforations and use of Artelon® Tissue Reinforcement, a synthetic device based on degradable polyurethaneurea.
The investigators believe that this kind of tendon-to-bone healing stimulation with the two proposed methods can increase the repair quality by significantly decreasing the lesion recurrence rate (currently described for 15% of patients) and can improve various parameters such as pain, range of motion and strength, thereby hastening the return to daily activities and psycho-physical well-being.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double Blind
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a medium rotator cuff tear (from 1 to 3 cm, according to Cofield Classification) with an indication for arthroscopic repair
- •signed informed consensus
排除标准
- •previous fractures
- •subscapularis tears
- •tears < 1cm or > 3 cm
- •reduced passive range of motion
- •infections
- •known mental or neurological disorders unwilling or unable to follow the post-surgery instructions
- •conditions that contraindicate arthroscopic rotator cuff surgery
- •patients without complete osteogenesis
- •pregnant or breastfeeding women
结局指标
主要结局
Retear rate
时间窗: 12 months post-operatively
Comparison of re-ruptures rate in each group evaluated with magnetic resonance imaging
次要结局
- Constant-Murley(3, 6, 12 months post-operatively)
- DASH(1, 3, 6, 12 months post-operatively)
- VAS(1, 3, 6, 12 months post-operatively)
- Passive ROM(1, 3, 6, 12 months post-operatively)
- Adverse events(1, 3, 6, 12 months post-operatively)
研究者
Roberto Leo
MD
ASST Gaetano Pini-CTO