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

Jonathan A Cook1,2, Naomi Merritt2, Jonathan L Rees2

  • 11Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.

Pilot and Feasibility Studies
|January 2, 2019
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Summary
This summary is machine-generated.

This study explores using patch augmentation for rotator cuff surgery. The goal is to design a trial to test if these patches improve surgical outcomes and are feasible for patients and surgeons.

Keywords:
Dermal matrixFeasibility studyRandomised trialRotator cuff tearShoulder surgerySurgical meshTissue scaffold

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Area of Science:

  • Orthopedic Surgery
  • Biomaterials Science
  • Clinical Trial Design

Background:

  • Rotator cuff tears cause significant disability, pain, and weakness, often requiring surgery with high failure rates.
  • Patch augmentation is a promising approach to support healing and improve outcomes in rotator cuff repair.
  • Limited clinical evidence exists for the effectiveness of various patch materials and designs.

Purpose of the Study:

  • To determine the feasibility and acceptability of a randomized trial for patch-augmented rotator cuff surgery (PARCS).
  • To inform the design of a definitive trial assessing the effectiveness and cost-effectiveness of rotator cuff patches.
  • To gather stakeholder consensus on the optimal trial design.

Main Methods:

  • A six-stage mixed-methods approach was employed.
  • Methods included a systematic literature review, surgeon surveys, stakeholder focus groups/interviews, a Delphi study, and a consensus meeting.
  • Involved diverse stakeholders: patients, surgeons, industry, NHS, and regulatory bodies.

Main Results:

  • The study successfully informed the feasibility and acceptability of a randomized trial for patch-augmented rotator cuff surgery.
  • Consensus was sought on the fundamental design elements for such a trial.
  • Identified key considerations for trial design based on stakeholder input and existing evidence.

Conclusions:

  • The PARCS feasibility study provides crucial insights for conducting a definitive trial on patch-augmented rotator cuff repair.
  • The findings will guide the development of a robust and acceptable randomized trial protocol.
  • This research aims to improve the success rates and patient outcomes of rotator cuff surgery through evidence-based augmentation techniques.