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Patch Augmented Rotator Cuff Surgery Study – A Feasibility Study

Background

A rotator cuff tear is a severe but common shoulder problem. It is found in around 25% of people aged 70 and above. Symptoms include pain, weakness, lack of shoulder mobility and sleep disturbance.

Initial management is conservative and includes rest with simple pain management. Many patients will require surgery to repair the tear. However, rotator cuff surgery has high failure rates perhaps 25-50% within 12 months. It is also expensive, invasive and inconvenient to patients. Re-operation is sometimes necessary. At a cost of around £6,500 per operation, roughly 9,000 rotator cuff repairs are performed each year in the NHS in England, and this number is still growing.

There is, therefore, a pressing need to improve the outcome of rotator cuff surgery.

Various surgical approaches have tried, unsuccessfully, to improve the outcome of rotator cuff repair. One approach, that appears promising, is the use of a patch to provide a support structure or 'scaffold' for the repair. The patch is surgically sutured on top of the tendon-to-bone repair to strengthen the repair, and aid the healing process, thereby reducing the likelihood of failure and improving patient outcomes.

Evidence on the use of patches is limited, at risk of bias, covers only a subset of the available patches in use, and is mixed in terms of clinical benefit.

The use of a patch to improve healing and patient outcomes requires rigorous evaluation.

There is a need for a well-designed randomised controlled trial.

However, there are key uncertainties about the design and conduct of such a trial, including;

  • Which patches are used in the NHS,
  • Which should be evaluated in a trial,
  • Which patients would benefit most,
  • How the surgery should be delivered, and
  • Which outcomes should be measured?

The feasibility and acceptability to stakeholders of such a trial must be considered to ensure it is relevant, scientifically sound and viable.

Study Aim/ Design

We have designed a six-stage mixed methods feasibility study to:                                                                                                         

  • Determine current practice, evidence and views about patch use to augment rotator cuff repair,
  • 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 study will comprise six stages.

Stage 1: involves conducting a systematic review of candidate patches and clinical evidence on their use to update and expand two existing systematic reviews.

Stages 2 and 3: involves surveying shoulder surgeons to assess current practice, views on patient suitability and what would alter their practice.

Stage 4: involves conducting focus groups with members of key stakeholder groups (including patient and surgeons amongst others). Topics will vary by stakeholder group (e.g. patients’ views on patch use).

Stage 5: involves undertaking a Delphi study to achieve initial consensus on the trial design (e.g. patch types to be evaluated, control group definition, outcomes, etc.).

Stage 6: involves holding a face-to-face consensus meeting of stakeholders to review the study findings and agree the trial design.

 

 

 

Our Team (External Collaborators)

Dr Joanna Crocker, Research Fellow, Nuffield Department of Primary Care Health Sciences, University of Oxford
Dair Farrar-Hockley, Patient Representative
Dr Lucksy Kottam, Career Scientist, South Tees Hospitals NHS Foundation Trust
Mr Michael Thomas, Consultant Orthopaedic Surgeon, Frimley Park Hospital NHS Foundation Trust

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Getting involved

If you're interested in getting involved with our trials, please contact each project directly.

Thank you.

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