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Effectiveness of Surgery for Atraumatic Shoulder Instability

Sponsor
Royal National Orthopaedic Hospital NHS Trust (Other)
Overall Status
Recruiting
CT.gov ID
NCT01751490
Collaborator
University of Sydney (Other)
140
Enrollment
1
Location
2
Arms
117.9
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: physiotherapy
  • Procedure: shoulder stabilisation surgery
 N/A

Detailed Description

A two-arm, patient, physiotherapist and assessor-blinded, randomised controlled clinical trial will be conducted. 140 patients will be randomly allocated into one of 2 groups: a stabilisation surgery group and a control group. Primary outcomes (pain and disability) and secondary outcomes (participant-reported improvement and incidence of shoulder dislocations) will be evaluated at baseline and 6, 12 and 24 months after randomisation. Additional secondary outcomes of shoulder rotation range of motion and strength will be evaluated 6 months after randomisation.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Does Surgery Followed by Physiotherapy Improve Short and Long Term Outcomes for Patients With Atraumatic Shoulder Instability Compared With Physiotherapy Alone?
Study Start Date :
Feb 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: physiotherapy alone

patients undergoing physiotherapy only

Other: physiotherapy
physiotherapy

Procedure: shoulder stabilisation surgery
arthroscopic stabilisation surgery
Other Names:
  • arthroscopic stabilisation surgery

    		•
    Active Comparator: surgery and physiotherpay

    patients receiving surgical treatment followed by physiotherapy

    Other: physiotherapy
    physiotherapy

    Procedure: shoulder stabilisation surgery
    arthroscopic stabilisation surgery
    Other Names:
  • arthroscopic stabilisation surgery

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in pain and functional impairment, measured using the Western Ontario Shoulder Instability Index. [over 24 months]

      Looking at time points of baseline, 6 months, 12 months and 24 months

    Secondary Outcome Measures

    1. Global perceived effect assessing participant-perceived improvement [over 24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • feelings of insecurity (apprehension) at their shoulder joint

    • provocation of apprehension with drawer and apprehension tests

    • evidence labral/capsular injury in the shoulder joint

    Exclusion Criteria:

    • a history of a high collision shoulder injury precipitating apprehension symptoms

    • evidence of bony injury around glenoid rim/and or humeral head

    • a pristine joint i.e. no evidence of any structural injury to the joint, capsule or labrum.

    • a rotator cuff tear

    • neural damage affecting the upper limb

    • previous shoulder surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Royal National Orthopaedic Hospital NHS Trust Stanmore Middlesex United Kingdom HA7 4LP

    Sponsors and Collaborators

    • Royal National Orthopaedic Hospital NHS Trust
    • University of Sydney

    Investigators

    • Principal Investigator: Anju Jaggi, BSc, Royal National Orthopaedic Hospital NHS Trust
    • Principal Investigator: Susan Alexander, MD, Royal National Orthopaedic Hospital NHS Trust & UCL
    • Principal Investigator: Karen Ginn, BSc, PhD, University of Sydney
    • Principal Investigator: Andrew Symonds, BSc, MSc, Royal National Orthopaedic Hospital NHS Trust
    • Principal Investigator: Suzie Cro, BSc, Royal National Orthopaedic Hospital NHS Trust

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Iva Hauptmannova, Sponsor representative, Royal National Orthopaedic Hospital NHS Trust
    ClinicalTrials.gov Identifier:
    NCT01751490
    Other Study ID Numbers:
    • 12.024
    First Posted:
    Dec 18, 2012
    Last Update Posted:
    May 5, 2022
    Last Verified:
    May 1, 2022
    Keywords provided by Iva Hauptmannova, Sponsor representative, Royal National Orthopaedic Hospital NHS Trust
    shoulder
    instability
    atraumatic
    Additional relevant MeSH terms:
    Joint Instability

    Study Results

    No Results Posted as of May 5, 2022