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Effectiveness of Surgery for Atraumatic Shoulder Instability

NCT01751490 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-04-25

No results posted yet for this study

Summary

We will conduct a randomised clinical trial with the primary aim of determining whether surgical intervention followed by physiotherapy rehabilitation improves pain and disability outcomes more than physiotherapy rehabilitation alone in patients suffering from atraumatic shoulder instability associated with bony/capsulolabral damage. The results of this study will have direct and immediate impact on clinical decision making by establishing definitively if patients presenting with joint damage associated with atraumatic shoulder instability should be referred for surgery before commencing physiotherapy rehabilitation. The results of this study may also result in significant cost savings to the National Health Service if surgical intervention for atraumatic shoulder instability does not result in greater improvement than physiotherapy alone.

Conditions

  • Atraumatic Shoulder Instability

Interventions

OTHER

physiotherapy

physiotherapy

PROCEDURE

shoulder stabilisation surgery

arthroscopic stabilisation surgery

Sponsors & Collaborators

  • University of Sydney

    collaborator OTHER

  • Royal National Orthopaedic Hospital NHS Trust

    lead OTHER

Principal Investigators

  • Anju Jaggi, BSc · Royal National Orthopaedic Hospital NHS Trust

  • Susan Alexander, MD · Royal National Orthopaedic Hospital NHS Trust & UCL

  • Karen Ginn, BSc, PhD · University of Sydney

  • Andrew Symonds, BSc, MSc · Royal National Orthopaedic Hospital NHS Trust

  • Suzie Cro, BSc · Royal National Orthopaedic Hospital NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2022-12-31
Completion
2022-12-31

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 NCT01751490 on ClinicalTrials.gov