Surgery Versus PhysiothErapist-leD Exercise for Traumatic Tears of the Rotator Cuff

NCT04027205 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-02-18

No results posted yet for this study

Summary

The SPeEDy study is a parallel group, pilot and feasibility randomised controlled trial (RCT) with integrated Quintet Recruitment Intervention (QRI) and further qualitative interviews. The study hypothesis is: In adult patients diagnosed with traumatic tears of the rotator cuff, is it feasible to conduct a future, substantive, multi-site RCT to test the hypothesis that physiotherapist-led exercise is not inferior to surgical repair of the rotator cuff in terms of clinical outcomes but is more cost-effective.

Conditions

  • Traumatic Rotator Cuff Tear

Interventions

OTHER

Physiotherapist-led exercise

A programme of physiotherapist-led exercise over approximately 12 weeks.

PROCEDURE

Surgical repair

Surgical repair of the rotator cuff plus usual post-operative rehabilitation

Sponsors & Collaborators

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV
  • University Hospitals of Derby and Burton NHS Foundation Trust

    collaborator OTHER
  • University Hospitals, Leicester

    collaborator OTHER
  • Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

    collaborator OTHER_GOV
  • University Hospitals of North Midlands NHS Trust

    collaborator OTHER
  • University Hospitals Coventry and Warwickshire NHS Trust

    collaborator OTHER
  • Airedale NHS Foundation Trust

    collaborator OTHER
  • Liverpool University Hospitals NHS Foundation Trust

    collaborator OTHER_GOV
  • University Hospital Birmingham NHS Foundation Trust

    collaborator OTHER
  • Keele University

    lead OTHER

Principal Investigators

  • Chris Littlewood, PhD · Manchester Metropolitan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-03
Primary Completion
2021-02-03
Completion
2021-02-03

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04027205 on ClinicalTrials.gov