Biological Augmentation With Subacromial Bursa in Arthroscopic Rotator Cuff Repair - Postoperative Findings Using Doppler Ultrasonography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Dynamic ultrasound examination with grading of blood vessels
研究概览
简要总结
The aim of this first study is to investigate in a case series through sequential sonographic imaging, using Doppler ultrasonography, the postoperative morphology, especially vascularity and findings of neovascularity, after bursa augmentation in arthroscopic rotator cuff repair.
详细描述
The outcome of rotator cuff (RC) reconstruction with and without bursa augmentation, considering also the inflammatory status of the bursa, will be systematically investigated for the first time. The influencing role of the inflammatory status of the bursa, of the RC tendon and the synovial membrane at the time of the operation on the tendinous healing rate, the patient-relevant outcome factors and the revision rate will be assessed. In a further approach, basic knowledge about the role of bursa inflammation and its influence in the development and regeneration of tendon pathologies shall be gained. The findings of the whole project could lead to improve tendon healing in the reconstruction of the rotator cuff, taking advantage of augmentation potential of the subacromial bursa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 years and older
- •Patient with C-shaped posterosuperior rotator cuff tear (SSP / ± ISP, ± SCP Tear Lafosse ≤ 1 (SCP no repair, only debridement))
- •Retraction ≤ 2 according to Patte
- •Fatty infiltration ≤ 2 according to Goutallier
- •Eligible for arthroscopic double row rotator cuff repair in Suture Bridge technique.
- •Written informed consent
排除标准
- •Legal incompetence
- •Last subacromial cortisone infiltration ≤ 6 months
- •Systemic rheumatologic-inflammatory disease
- •Diabetes Mellitus
结局指标
主要结局
Dynamic ultrasound examination with grading of blood vessels
时间窗: 3 months
using the modified Ohberg Score
次要结局
- Tendon condition(6 months)
- Subjective shoulder value (SSV)(6 months)
- Oxford Shoulder Score (OSS)(6 months)
- Level of satisfaction(6 months)
- Tendon integrity(6 months)
- Range of motion(6 months)
- Shoulder muscle strength(6 months)
- Constant Murley score (CMS)(6 months)
- EQ-5D utilities(6 months)
- Adverse events(6 months)