Multicenter randomized prospective non-inferiority trial for the comparison of clinical outcomes between subacromial spacer insertion and rotator cuff repair for massive rotator cuff tear

Seoul National University Bundang Hospital0 个研究点目标入组 306 人开始时间: 待定最近更新: 2024年6月24日

适应症

试验速览

暂无简介。

•1) Men and women older than 40 years of age
•2) No symptom relief despite more than 3 months of conservative treatment
•3) Greater than 3 centimeters of posterosuperior cuff tear or 2.5 cm of posterosuperior cuff tear with subscapularis tear, and when they require surgical treatment.
•4) No known problem with the deltoid muscle
•5) Tear associated factors (anteroposterior tear size, retraction size, fatty degeneration of the infraspinatus) in the RoHI classification greater than 6 out of total 9.

•1) Previous surgery on the same side shoulder.
•2) Concomitant osteoarthritis or history of treatment for infection in the ipsilateral shoulder.
•3) Full-thickness injury of the cartilage on MRI.
•4) Acute traumatic rotator cuff tear
•5) Patients with less than 1 year of outpatient follow-up after surgery
•6) Patients with possibility of pregnancy.
•7) Pain Visual analogue scale (VAS) score greater than 3 on the contralateral shoulder.
•8) Allergic to Copolymer of PLA and -e-caprolactone, ingridients of Inspace?.
•9) Autoimmune disease or HIV Ab (+)
•10) Those that do not consent to the study
•11) Those that are participating in other clinical trials.

发起方