Title: Patch Augmented Rotator Cuff Surgery Study(PARCS) - A feasibility study
Funder: Department of Health and Social Care

Abstract: Design: A six-stage mixed methods feasibility study 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. Methods: The study will comprise six stages. In Stage 1, a systematic review of candidate patches and clinical evidence on their use will be conducted to update and expand two existing systematic reviews. Electronic searches and other methods will be used to identify reports of candidate patches in the published, unpublished and grey literature (including multiple databases, conference proceeding and trial registries). Two reviewers will screen titles and abstracts and assess the full texts, abstracting the patch details, study design, patient population, setting, outcomes and findings. In Stages 2 and 3 shoulder surgeons will be invited to respond to an online survey additionally asking about their views on outcomes and site practicalities (including personal willingness to participate and perceived challenges to recruitment). In Stage 4, multiple focus groups will be conducted with key stakeholders (rotator cuff patients, regulatory body, industry representatives, and NHS commissioners/procurers). Topics will vary by stakeholder group represented (e.g. patients’ views on patch use, outcomes and willingness to participate in a trial). In Stage 5, an online Delphi process will be carried out to achieve initial consensus on the trial design. Round one will be based on Stages 1 - 4 and will include the patch types to be evaluated, control group definition, outcomes (primary outcome and target difference), follow-up assessments, acceptability and feasibility of the trial. In Stage 6, a face-to-face consensus meeting of stakeholders (surgeons, trialists, funders, industry and patients) will be held to review the findings and agree the trial design. Target condition: Patients requiring surgery for a rotator cuff tear. Health technologies being assessed: Rotator cuff surgery with/without surgical augmentation using a patch. Setting: Patients, surgeons, trialists, NHS commissioners/procurers, regulatory and industry representatives. Study outputs: Ascertain the evidence base and current practice; elicit views on patch-augmented surgery; determine the trial design, including patient eligibility, intervention and control group definitions, and outcomes; and assess the acceptability and feasibility of the trial. Project timetable: M1-6 Stages 1&2, M7-13 Stages 3&4, M14-19 Stage 5, M20 Stage 6, M21 Write up. Expertise in team: This multidisciplinary team includes patients, shoulder surgeons, trialists, methodologists and a trial manager. It has the full support of a clinical trials unit (OCTRU) and a surgical trials unit (SITU), and representation from the key professional body (BESS).

Lay abstract: Background to the study: Shoulder muscles and tendons allow us to move our arms, carry out daily activities, work and play sport. Pain arising from disease and injury of these tendons can cause significant long-term disability. Shoulder pain is the third most common reason why people visit their GPs. The early treatment of rotator cuff tendon problems usually involves prescribing painkillers, and also injections and/or physiotherapy. However, approximately 40% of patients will have continued pain and many require surgery. Around 9,000 patients in England each year are operated on to repair torn shoulder tendons, and this number has been increasing year on year. The need for this study: A recent study established that 40% of surgical tendon repairs fail within twelve months, which can result in long-term disability. Poor tissue quality is thought to be a key cause of this failure. We need to improve the outcome of the operation. A number of approaches for improving tendon repair operations have been attempted but with little success. One very promising approach is to use a patch to support the surgical repair while the tendon heals, functioning in a similar way to a splint. Laboratory studies have been encouraging, although studies with patients have had mixed findings. Some patches made from human or pig tissue have resulted in adverse reactions in patients. Developers are trying alternative materials, such as plastics that are already commonly used in surgery. These are less likely to provoke an adverse reaction and may also stimulate tendon healing in the early post-surgery stage of recovery. However, it is not yet clear whether any of the patches do indeed improve patient health and, if so, whether the improvement is sufficient to justify the additional cost to the NHS. Research plan: A scientific study called a randomised trial is needed to fairly assess the value of surgery with a patch. This study must be carefully designed, for example by ensuring that the right patches are evaluated, the outcomes measured are important to patients and the surgical approach is appropriate. We will use a six-stage approach to determine how to conduct a fair and relevant study that is acceptable to patients and surgeons amongst others, and feasible to run. In Stage 1, we will search the scientific literature for all reports of using patches in patients. In Stages 2 and 3, we will survey surgeons involved in this type of research to find out which patches are currently used. We will conduct focus groups in Stage 4 with stakeholders such as patients, researchers and NHS managers, and company representatives to incorporate their views and understanding of living with a rotator cuff tear and receiving surgery. In Stage 5, we will begin developing a consensus on the best way to run a randomised trial of patches in shoulder surgery by using multiple rounds of an online questionnaire. Rounds will incorporate findings from Stages 1-4 and the previous round. In Stage 6, we will hold a face-to-face meeting with key stakeholders, including surgeons and patients, to reach a final consensus. The team: We have assembled a research team comprising patient representatives, surgeons and scientists working in this area to carry out this research. This project will help guide treatment of shoulder tendon tear to improve patient health.

Research activity codes: 6.3 MEDICAL DEVICES;6.4 SURGERY
Health categories: MUSCULOSKELETAL