Effectiveness of Surgery for Atraumatic Shoulder Instability

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Royal National Orthopaedic Hospital NHS Trust
Sponsor:
Collaborator:
University of Sydney
Information provided by (Responsible Party):
Iva Hauptmannova, Royal National Orthopaedic Hospital NHS Trust
ClinicalTrials.gov Identifier:
NCT01751490
First received: December 5, 2012
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

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 Intervention
Atraumatic Shoulder Instability
Other: physiotherapy
Procedure: shoulder stabilisation surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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?

Resource links provided by NLM:


Further study details as provided by Royal National Orthopaedic Hospital NHS Trust:

Primary Outcome Measures:
  • Change in pain and functional impairment, measured using the Western Ontario Shoulder Instability Index. [ Time Frame: over 24 months ] [ Designated as safety issue: No ]
    Looking at time points of baseline, 6 months, 12 months and 24 months


Secondary Outcome Measures:
  • Global perceived effect assessing participant-perceived improvement [ Time Frame: over 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: February 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: physiotherapy alone
patients undergoing physiotherapy only
Other: physiotherapy
physiotherapy
Procedure: shoulder stabilisation surgery
arthroscopic stabilisation surgery
Other Name: 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 Name: arthroscopic stabilisation surgery

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01751490

Contacts
Contact: Iva Hauptmannova, BSc, MA 0044(0)208909 5529 ext 5529 research@rnoh.nhs.uk
Contact: Anju Jaggi, BSc 0044(0)2089542300 ext 2300 anju.jaggi@rnoh.nhs.uk

Locations
United Kingdom
Royal National Orthopaedic Hospital NHS Trust Recruiting
Stanmore, Middlesex, United Kingdom, HA7 4LP
Contact: Iva Hauptmannova, BSc, MA    0044(0)2086065529    research@rnoh.nhs.uk   
Contact: Anju Jaggi, BSc    0044(0)2089542300    anju.jaggi@rnoh.nhs.uk   
Principal Investigator: Anju Jaggi         
Sub-Investigator: Susan Alexander         
Sub-Investigator: Andrew Symonds         
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 The 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
  More Information

Additional Information:
No publications provided

Responsible Party: Iva Hauptmannova, Sponsor representative, Royal National Orthopaedic Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT01751490     History of Changes
Other Study ID Numbers: 12.024
Study First Received: December 5, 2012
Last Updated: May 2, 2014
Health Authority: United Kingdom: Department of Health

Keywords provided by Royal National Orthopaedic Hospital NHS Trust:
shoulder
instability
atraumatic

ClinicalTrials.gov processed this record on September 15, 2014