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
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