REGENETEN patient registry (RePaRe): a protocol for a prospective, multi-centre registry to evaluate clinical and health economic outcomes following the use of a bioinductive collagen implant in rotator cuff repair

Abstract This protocol describes a prospective post-market, observational registry to assess clinical and patient-reported outcomes following the use of a bioinductive collagen implant in rotator cuff repair. The registry is live in the UK and opening sites in Germany, France, Italy and Australia imminently. Clinical data such as rotator cuff tear type, surgery description and post-operative recommendations is collected after surgery. Information on patient work and social activity capabilities as well as PROMs (Oxford Shoulder Score, VAS Pain, SANE, Quick DASH and EQ5D-5 L) are collected pre-operatively and at 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months post-operatively. Inclusion criteria are patients older than 18 years, for whom their surgeon has determined that the bioinductive collagen implant is appropriate in their rotator cuff repair surgery. Ethical approval has been obtained from all appropriate committees in each participating country.