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Hannah Thompson BME9 MSc Biomedical Engineering 1 Mechanical optimisation of rotator cuff tendon augmentation patches Chapter 1: Introduction and Aims of study 1.1 Introduction Over 30% of the UK population each year seek medical attention due to shoulder discomfort caused by tendon damage 1 . There are four tendons in the shoulder; the tendons of the subscapularis, supraspinatus, infraspinatus, and teres minor, and they are collectively known as the rotator cuff tendons. Disorders of the rotator cuff, which are the most common cause of shoulder problems, result in excruciating pain for the  patient, and significan tly reduce quality of life 2 . Rotator cuff disorders include tears of any of the four rotator cuff tendons, and the prevalence of full and partial thickness tears has been found to increase significantly with age. This is illustrated in a study involving 90 subjects, where the prevalence of full thickness tears was 80% in subjects over 80, compared to just 31% in subjects over 50 3 . Despite the prevalence of rotator cuff tendon tears increasing with age, largely as a result of chronic degenerative processes, acute traumatic injuries, such as large tears and complete ruptures, do occur in the younger population, usually whilst undertaking sports that subject the shoulder to very high stresses and strains 4 . There are currently two treatment options available for rotator cuff tendon disorders; surgery (arthroscopic or open), where fixation is achieved using sutures, or physical therapy (an exercise regime) 4 . In a clinical trial, of the 44 who undertook an exercise regime to treat rotator cuff tendon tears, only 27 had a good or excellent outcome, while a similar outcome (26/38) was obtained for those who underwent surgery 5 . Thus, for a third of patients who underwent surgical or rehabilitation treatment, pain and disability caused by the torn rotator cuff tendon was not improved, and a recent Cochrane review found there to be insufficient evidence currently available to show that surgery for rotator cuff tendon disorders is effective 5,6 . Many scientists strongly believe that rotator cuff tendon augmentation patches have the potential to significantly improve the current success rate of rotator cuff tendon surgery 1,7,8 . These patches should address two challenges: promoting the regeneration of the native tendon-to-bone interface, and hence, enhancing the healing potential of tendon, and also providing adequate strength, thereby protecting the sutured tendon tear from failure due to suture pull-out at the suture  – tendon interface 8,9,10 . Consequently, there are two main aims of a tendon augmentation patch. The first is to act as a mechanical support during the critical repair window, which is the first 8 weeks of tendon healing, so protecting the repair from tensile loads, and the second is to deliver biological factors to the repair site, that will enhance the healing process, as the patch degrades 11,12 .

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