A feasibility and efficacy trial evaluating a suturing augmentation device for rotator cuff repairs
Shoulder muscles and tendons allow us to move our arms, carry out daily activities, work and play sport. Pain arising from disease and injury to these tendons can cause significant long term disability. Shoulder pain is the third commonest orthopaedic problem to present to general practitioners. Currently 10,000 patients annually in England have torn tendons that require surgical repair and this number is increasing. Unfortunately around 40% of these surgical repairs fail, which can result in long term disability.
The team in Oxford have developed a new type of stitching (suture) material called Bioyarn. It is made of very fine synthetic degradable fibres that mimic a normal tendon. The Oxford team, lead by Professor Carr believe that this new material will promote much better healing when used instead of conventional sutures to bind the torn tendon to the bone. The team propose to further evaluate Bioyarn before undertaking a feasibility study in humans to determine if the Bioyarn can be used safely and then conduct a randomised clinical trial to see if using the Bioyarn reduces the number of repair failures compared to surgery using the commercial sutures currently available to surgeons. The Oxford team aim to reduce significantly the current failure rate of surgery and to improve patient outcomes.