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. 2018 Dec 21:4:188.
doi: 10.1186/s40814-018-0380-7. eCollection 2018.

Patch-augmented rotator cuff surgery (PARCS) study-protocol for a feasibility study

Jonathan A Cook  1   2 , Naomi Merritt  2 , Jonathan L Rees  2 , Joanna C Crocker  3   4 , Sally Hopewell  1 , Melina Dritsaki  1 , David J Beard  2 , Amar Rangan  2   5 , Cushla Cooper  2 , Lucksy Kottam  5 , Dair Farrar-Hockley  2 , Michael Thomas  6 , Robert Earle  2 , Andrew J Carr  2
Affiliations

Patch-augmented rotator cuff surgery (PARCS) study-protocol for a feasibility study

Jonathan A Cook et al. Pilot Feasibility Stud. .

Abstract

Background: A rotator cuff tear is a common disabling shoulder problem. Symptoms include pain, weakness, lack of shoulder 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 and the use of patch augmentation to provide support to the healing process and improve patient outcomes holds new promise. Patches have been made using different materials (e.g. human/animal skin or intestine tissue, and completely synthetic materials) and processes (e.g. woven or a mesh). However, clinical evidence on their use is limited. The aim of the patch-augmented rotator cuff surgery (PARCS) feasibility study is to determine, using a mixed method approach, the design of a definitive randomised trial 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: The objectives of this six-stage mixed methods feasibility study are to determine current practice, evidence and views about patch use; achieve consensus on the design of a randomised trial to evaluate patch-augmented rotator cuff surgery; and assess the acceptability and feasibility of the proposed design. The six stages will involve a systematic review of clinical evidence, two surveys of surgeons, focus groups and interviews with stakeholders, a Delphi study and a consensus meeting. The various stakeholders (including patients, surgeons, and representatives from industry, the NHS and regulatory bodies) will be involved across the six stages.

Discussion: The PARCS feasibility study will inform the feasibility and acceptability of a randomised trial of the effectiveness and cost-effectiveness of a patch-augmented rotator cuff surgery. Consensus opinion on the basic design of a randomised trial will be sought.

Trial registration: Not applicable.

Keywords: Dermal matrix; Feasibility study; Randomised trial; Rotator cuff tear; Shoulder surgery; Surgical mesh; Tissue scaffold.

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Conflict of interest statement

This feasibility study was reviewed and approved to proceed by the University of Oxford Joint Research Office (JRO) study classification group (ref: PID13023). The JRO determined that the PARCS study falls outside of the definition of research that requires Health Research Authority (HRA) ethical approval and is therefore was not subject to the Department of Health’s Research Governance Framework for Health and Social Care (2005). It does not therefore require further assessment or approval prior to commencement. Informed Consent will be sought from participants as detailed in the main body of this paper.Not applicable.Andrew Carr has applied for a patent that will be considered as part of this work. We have carefully designed a robust research strategy that incorporates substantial independent input throughout to ensure no other individual, whether they be within or out the project team, can have undue influence on the process. Amar Rangan has received educational and research grants from DePuy Ltd. outside the scope of this work. The authors declare that they have no conflict of interest.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study flow chart. Patch-augmented rotator cuff repair study (PARCS)
See this image and copyright information in PMC

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