Findings from the patch augmented rotator cuff surgery (PARCS) feasibility study
نویسندگان
چکیده
Abstract Background A rotator cuff tear is a common disabling shoulder problem. Symptoms include pain, weakness, lack of mobility and sleep disturbance. Many patients require surgery to repair the tear; however, there high failure rate. There pressing need improve outcome surgery. The use patch augmentation provide support healing process patient outcomes holds new promise. Different materials (e.g. human/animal skin or intestine tissue, completely synthetic materials) processes woven mesh) have been used produce patches. However, clinical evidence on their limited. augmented (PARCS) feasibility study aimed determine design definitive randomised controlled trial (RCT) assessing effectiveness cost-effectiveness augment surgical that both acceptable stakeholders feasible. Methods mixed methods conducing subsequent RCT. project involved six stages: systematic review evidence; survey British Elbow Shoulder Society’s (BESS) membership; surgeon trialists; focus groups interviews with stakeholders; two-round Delphi administered via online questionnaires 2-day consensus meeting. Results BESS surgeons’ identified variety patches in (105 (21%) responses received). Twenty-four surgeons (77%) completed trialist relating design. Four were conducted involving 24 stakeholders. Twenty-nine (67% invited) individuals took part Delphi. Differing views held number aspects including appropriate population for participation. Agreement key research questions outline two potential RCTs achieved through Conclusions Randomised comparisons on-lay repairs, bridging partial repairs as areas further research. value an observational assess safety concerns was also highlighted. main limitation findings influenced by participants, who might not necessarily reflect all
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ژورنال
عنوان ژورنال: Pilot and Feasibility Studies
سال: 2021
ISSN: ['2055-5784']
DOI: https://doi.org/10.1186/s40814-021-00899-9