Stem cell treatment for regeneration of the rotator cuff: study protocol for a prospective single-center randomized controlled trial (Lipo-cuff).

Several human studies show positive signals, while research methods and sample sizes continue to develop.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

Background Rotator cuff tears (RCT) are a common musculoskeletal condition, especially in the aging population. The prevalence of rotator cuff tears varies based on factors like age, occupation, and activity level. In the general population, the prevalence of rotator cuff tears is estimated to be around 20 to 25%. Rotator cuff tears (RCT) have an impact in patients' pain level, shoulder function, sleep disturbance, and quality of life. Primary tendon surgery is in mostly cases necessary. This study aimed to examine if treatment of rotator cuff lesions with implantation of micro-fragmented adipose tissue can improve patients' reported pain and function compared to conventional surgery. Methods The study is a prospective superiority parallel-group single-center randomized controlled trial including 30 patients between 40 and 69 years of age in Denmark. Patients will be allocated 1:1 ratio to reconstruction of the supraspinatus tendon with an injection of micro-fragmented adipose tissue into the related muscle (stem cell treatment) or the standard of care (SOC), which is conventional surgery. Patients, project assistants, physicians, and outcome adjudicators are not blinded to randomization due to practical constraints. The radiologist and the statistician performing the analysis will be blinded. The primary outcome will be the Oxford shoulder score at 12 months post-surgery. Disc

Evidence level

Several human studies show positive signals, while research methods and sample sizes continue to develop.

Browse all related research

Filter the research library by this study's title keywords, author, or publication year.