Condition category
Surgery
Date applied
07/08/2017
Date assigned
10/08/2017
Last edited
08/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Type

Scientific

Primary contact

Mr Sriskandarasa Senthilkumaran

ORCID ID

http://orcid.org/0000-0002-7043-5339

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10/S0802/39

Study information

Scientific title

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

Acronym

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Arthroscopic anterior shoulder stabilisation for instability

Intervention

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

Other

Phase

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

01/08/2010

Overall trial end date

30/08/2015

Reason abandoned (if study stopped)

Eligibility

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

Patient

Age group

Adult

Gender

Both

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

25/08/2010

Recruitment end date

10/07/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Woodend General Hospital
93 Eday Road
Aberdeen
AB15 6XS
United Kingdom

Sponsor information

Organisation

NHS Grampian R&D

Sponsor details

Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB25 2ZN
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

NHS Grampian R&D

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

08/11/2017

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes