Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Arthroscopic shoulder stabilisation is a commonly performed operation to treat recurrent dislocation of the shoulder. There is lack of agreement about rehabilitation after arthroscopic shoulder stabilisation surgery, with most surgeons recommending immobilisation of the shoulder for three to six weeks after surgery to allow the ligaments to heal and prevent recurrence. However, one of the risks of prolonged immobilisation is residual shoulder stiffness. Advocates of early mobilisation argue that there is no apparent increased risk of recurrence and excess stiffness is avoided. It also permits early strengthening and exercises. The aim of this study is to assess the recurrence rate and shoulder function of patients after arthroscopic stabilisation of the shoulder with two different rehabilitation regimes.

Who can participate?
Patients with recurrent shoulder instability undergoing arthroscopic anterior shoulder stabilisation

What does the study involve?
On the day of surgery, participants are randomly allocated to either the early mobilisation (EM) or sling immobilisation (SI) group. The EM group is immediately allowed to move the shoulder freely as pain allows. The SI Group is kept in a sling for 6 weeks. All participants are followed up at 6 weeks, 3, 6, 12 and 24 months to assess their shoulder function and to find out whether the surgery has worked or not.

What are the possible benefits and risks of participating?
The results will show which rehabilitation programme is best for patients undergoing arthroscopic shoulder stabilisation surgery. Possible benefits of early mobilisation include reduced risk of stiffness and increased proprioception (the body's ability to sense joint movement and position). The risk of early mobilisation is the theoretical risk of the surgical repair failing.

Where is the study run from?
Woodend General Hospital (UK)

When is the study starting and how long is it expected to run for?
August 2010 to August 2015

Who is funding the study?
NHS Grampian R&D (UK)

Who is the main contact?
Mr Sriskandarasa Senthilkumaran

Trial website

Contact information



Primary contact

Mr Sriskandarasa Senthilkumaran


Contact details

Department of Orthopaedics
Woodend General Hospital
Eday Road
AB15 6XS
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Randomised control study to compare sling immobilisation with early mobilisation in patients undergoing arthroscopic anterior shoulder stabilisation surgery


Study hypothesis

There should be no difference in the recurrence rate and shoulder function between the sling immobilisation and early mobilisation groups.

Ethics approval

NHS Grampian R&D, 30/06/2010, ref: 10/S0802/39

Study design

Single-centre single-blind randomised control trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Arthroscopic anterior shoulder stabilisation for instability


On the day of surgery, participants were randomised using sealed envelopes to either early mobilisation (EM) or sling immobilisation (SI) group. The EM group was allowed to move the shoulder freely as pain allowed immediately. The SI Group was kept in a sling for 6 weeks. All patients were followed up at 6 weeks, 3, 6, 12 and 24 months. Their function and failure of surgery were assessed using Oxford Shoulder Instability Score (OSIS).

Intervention type



Drug names

Primary outcome measure

Failure of surgery, defined as subluxation or redislocation at 6 weeks, 3 months, 6 months, 12 months and 24 months

Secondary outcome measures

Shoulder instability, assessed using the Oxford Shoulder Instability Score at pre-op, 6 weeks, 3 months, 6 months, 12 months and 24 months

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Patients with recurrent instability who had a Bankart lesion
2. Deemed suitable clinically and radiologically for an arthroscopic anterior shoulder stabilisation
3. No restriction on age

Participant type


Age group




Target number of participants

60 but stopped after 28

Participant exclusion criteria

1. Patients with previous failed stabilisation, multi-directional instability or posterior instability
2. Patients who were unwilling to participate

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Woodend General Hospital
93 Eday Road
AB15 6XS
United Kingdom

Sponsor information


NHS Grampian R&D

Sponsor details

Aberdeen Royal Infirmary
AB25 2ZN
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type

Hospital/treatment centre

Funder name

NHS Grampian R&D

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

The trialists are hoping to submit the study to a journal as soon as it is registered.

IPD sharing statement
The anonymised dataset will be available for review but not for sharing with other institutions as consent was not obtained for this. The data is kept by Mr Sriskandarasa Senthilkumaran and Mr Kapil Kumar (principal investigator for the study). Consent from participants was obtained for analysis.

Intention to publish date


Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/12/2019: The intention to publish date has been changed from 08/11/2017 to 30/06/2020. 26/11/2019: No publications found, verifying study status with principal investigator.