Findings from the patch augmented rotator cuff surgery (PARCS) feasibility study
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 is a high failure rate. There is a pressing need to improve the outcome of rotator...
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2021-08-01
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Series: | Pilot and Feasibility Studies |
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Online Access: | https://doi.org/10.1186/s40814-021-00899-9 |
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record_format |
Article |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Jonathan A. Cook Mathew Baldwin Cushla Cooper Navraj S. Nagra Joanna C. Crocker Molly Glaze Gemma Greenall Amar Rangan Lucksy Kottam Jonathan L. Rees Dair Farrar-Hockley Naomi Merritt Sally Hopewell David Beard Michael Thomas Melina Dritsaki Andrew J. Carr |
spellingShingle |
Jonathan A. Cook Mathew Baldwin Cushla Cooper Navraj S. Nagra Joanna C. Crocker Molly Glaze Gemma Greenall Amar Rangan Lucksy Kottam Jonathan L. Rees Dair Farrar-Hockley Naomi Merritt Sally Hopewell David Beard Michael Thomas Melina Dritsaki Andrew J. Carr Findings from the patch augmented rotator cuff surgery (PARCS) feasibility study Pilot and Feasibility Studies Rotator cuff tear Feasibility study Shoulder surgery Tissue scaffold Surgical mesh Dermal matrix |
author_facet |
Jonathan A. Cook Mathew Baldwin Cushla Cooper Navraj S. Nagra Joanna C. Crocker Molly Glaze Gemma Greenall Amar Rangan Lucksy Kottam Jonathan L. Rees Dair Farrar-Hockley Naomi Merritt Sally Hopewell David Beard Michael Thomas Melina Dritsaki Andrew J. Carr |
author_sort |
Jonathan A. Cook |
title |
Findings from the patch augmented rotator cuff surgery (PARCS) feasibility study |
title_short |
Findings from the patch augmented rotator cuff surgery (PARCS) feasibility study |
title_full |
Findings from the patch augmented rotator cuff surgery (PARCS) feasibility study |
title_fullStr |
Findings from the patch augmented rotator cuff surgery (PARCS) feasibility study |
title_full_unstemmed |
Findings from the patch augmented rotator cuff surgery (PARCS) feasibility study |
title_sort |
findings from the patch augmented rotator cuff surgery (parcs) feasibility study |
publisher |
BMC |
series |
Pilot and Feasibility Studies |
issn |
2055-5784 |
publishDate |
2021-08-01 |
description |
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 is a high failure rate. There is a pressing need to improve the outcome of rotator cuff surgery. The use of patch augmentation to provide support to the healing process and improve patient outcomes holds new promise. Different materials (e.g. human/animal skin or intestine tissue, and completely synthetic materials) and processes (e.g. woven or a mesh) have been used to produce patches. However, clinical evidence on their use is limited. The patch augmented rotator cuff surgery (PARCS) feasibility study aimed to determine the design of a definitive randomised controlled trial (RCT) assessing the effectiveness and cost-effectiveness of a patch to augment surgical repair of the rotator cuff that is both acceptable to stakeholders and feasible. Methods A mixed methods feasibility study of conducing a subsequent RCT. The project involved six stages: a systematic review of clinical evidence; a survey of the British Elbow and Shoulder Society’s (BESS) surgical membership; a survey of surgeon trialists; focus groups and interviews with stakeholders; a two-round Delphi study administered via online questionnaires and a 2-day consensus meeting. Results The BESS surgeons’ survey identified a variety of patches in use (105 (21%) responses received). Twenty-four surgeons (77%) completed the trialist survey relating to trial design. Four focus groups were conducted involving 24 stakeholders. Twenty-nine (67% of invited) individuals took part in the Delphi. Differing views were held on a number of aspects including the appropriate patient population for trial participation. Agreement on the key research questions and the outline of two potential RCTs were achieved through the Delphi study and the consensus meeting. Conclusions Randomised comparisons of on-lay patch use for completed rotator cuff repairs, and bridging patch use for partial rotator cuff repairs were identified as areas for further research. The value of an observational study to assess safety concerns of patch use was also highlighted. The main limitation was that the findings were influenced by the participants, who might not necessarily reflect all stakeholders. |
topic |
Rotator cuff tear Feasibility study Shoulder surgery Tissue scaffold Surgical mesh Dermal matrix |
url |
https://doi.org/10.1186/s40814-021-00899-9 |
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doaj-238eeb78d0c04b07aa9a68aaa37d33be2021-08-22T11:15:10ZengBMCPilot and Feasibility Studies2055-57842021-08-017111010.1186/s40814-021-00899-9Findings from the patch augmented rotator cuff surgery (PARCS) feasibility studyJonathan A. Cook0Mathew Baldwin1Cushla Cooper2Navraj S. Nagra3Joanna C. Crocker4Molly Glaze5Gemma Greenall6Amar Rangan7Lucksy Kottam8Jonathan L. Rees9Dair Farrar-Hockley10Naomi Merritt11Sally Hopewell12David Beard13Michael Thomas14Melina Dritsaki15Andrew J. Carr16Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of OxfordNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of OxfordNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of OxfordNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of OxfordNuffield Department of Primary Care Health Sciences, University of OxfordNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of OxfordNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of OxfordNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of OxfordThe James Cook University Hospital, South Tees Hospital NHS Foundation TrustNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of OxfordNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of OxfordNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of OxfordNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of OxfordNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of OxfordFrimley Health NHS Foundation TrustNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of OxfordNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of OxfordAbstract 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 is a high failure rate. There is a pressing need to improve the outcome of rotator cuff surgery. The use of patch augmentation to provide support to the healing process and improve patient outcomes holds new promise. Different materials (e.g. human/animal skin or intestine tissue, and completely synthetic materials) and processes (e.g. woven or a mesh) have been used to produce patches. However, clinical evidence on their use is limited. The patch augmented rotator cuff surgery (PARCS) feasibility study aimed to determine the design of a definitive randomised controlled trial (RCT) assessing the effectiveness and cost-effectiveness of a patch to augment surgical repair of the rotator cuff that is both acceptable to stakeholders and feasible. Methods A mixed methods feasibility study of conducing a subsequent RCT. The project involved six stages: a systematic review of clinical evidence; a survey of the British Elbow and Shoulder Society’s (BESS) surgical membership; a survey of surgeon trialists; focus groups and interviews with stakeholders; a two-round Delphi study administered via online questionnaires and a 2-day consensus meeting. Results The BESS surgeons’ survey identified a variety of patches in use (105 (21%) responses received). Twenty-four surgeons (77%) completed the trialist survey relating to trial design. Four focus groups were conducted involving 24 stakeholders. Twenty-nine (67% of invited) individuals took part in the Delphi. Differing views were held on a number of aspects including the appropriate patient population for trial participation. Agreement on the key research questions and the outline of two potential RCTs were achieved through the Delphi study and the consensus meeting. Conclusions Randomised comparisons of on-lay patch use for completed rotator cuff repairs, and bridging patch use for partial rotator cuff repairs were identified as areas for further research. The value of an observational study to assess safety concerns of patch use was also highlighted. The main limitation was that the findings were influenced by the participants, who might not necessarily reflect all stakeholders.https://doi.org/10.1186/s40814-021-00899-9Rotator cuff tearFeasibility studyShoulder surgeryTissue scaffoldSurgical meshDermal matrix |