Plain English Summary
Background and study aims
Patients who have undergone surgery for shoulder fractures have a reduced range of movement. We believe that this could be due to the traditional shoulder slings used after the operation. We believe that holding the shoulder in this position causes it to scar up and makes it difficult for the shoulder to externally rotate which reduces function. Using a neutral rotation brace will help improve patients external shoulder rotation and improve functional outcome. We would like to perform a study to compare the functional outcome with the two different slings.
Who can participate?
Patients over 18 who have shoulder fractures requiring surgery.
What does the study involve?
Participants will be randomly allocated to either having a traditional shoulder sling or a neutral rotation brace following the operation. They have to attend physiotherapy appointments at 6 weeks, 3 months, and 1 year after the operation. They will also complete some questionnaires. X-rays are taken (which is currently standard practice) at 6 weeks and 3 months to find out whether there is a fracture union (healing of the fracture) present. If there isnt a fracture union (similarly with current standard practice) patients will be followed up with x-rays until union is achieved.
What are the possible benefits and risks of participating?
The operation and post-operative treatment are standardised and no different from current practices. No increase in the number of side effects or complications is expected. Participants will help in changing current practice and improve patient functional outcome.
Where is the study run from?
Torbay District General Hospital, South Devon Healthcare NHS Foundation Trust (UK).
When is the study starting and how long is it expected to run for?
The study opened in January 2013 and is expected to continue until December 2015.
Who is funding the study?
Torbay Medical Research Fund (UK)
Who is the main contact?
Ms Veronica Conboy
veronica.conboy@nhs.net
Trial website
Contact information
Type
Scientific
Primary contact
Ms Veronica Conboy
ORCID ID
Contact details
Consultant in Trauma and Orthopaedics
Torbay District General Hospital
Lawes Bridge
Torquay
TQ2 7AA
United Kingdom
+44 (0)1803 656635
veronica.conboy@nhs.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT02073695
Protocol/serial number
13/01/049
Study information
Scientific title
Return Of funcTion And exTErnal rotation post proximal humerus fracture fixation with neutral rotation brace: a randomised controlled trial
Acronym
ROTATE
Study hypothesis
Using a neutral rotation brace will help improve patients external shoulder rotation and improve functional outcome.
Ethics approval
NRES Committee South West - Central Bristol, 22/01/2013, ref: 12/SW/0334
Study design
Single-centre randomised interventional 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 contact sdhct.research@nhs.net or phone: 01803 656635 to request a patient information sheet
Condition
Trauma and orthopaedics - proximal humeral fracture
Intervention
Surgical procedure to fix proximal humeral fracture, as per standard clinical practice, same across two groups. Patients are then randomised to either having the standard polysling (as per current standard practice) or a neutral rotation brace. Questionnaires and assessments will be taken at the 6 weeks, 3 months and 1 year follow up appointments.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Functional outcome scores will be measured post surgery (Oxford, scores). This is a commonly used, validated outcome score used for assessment of patient outcomes.
1. Oxford Score this is a patients subjective assessment of pain and Activities of Daily Living (ADL) impairment. The Oxford Shoulder Questionnaire has been shown to correlate well with both the Constant Score and the SF36 assessment and to be sensitive to surgical intervention. The Oxford Shoulder Questionnaire accumulates to a total score with a maximum value of 60, in which four pain related questions make up 33% of this total whilst the remaining 67% is derived from eight ADL related questions. The highest scores are attributed to the worst outcomes in the Oxford Shoulder Questionnaire.
2. The Disabilities of the Arm, Shoulder and Hand (DASH) scoring system was developed to assess the level of disability for any patient with any condition affecting the upper limb by covering domains including symptoms, physical function, social function and psychological function
Secondary outcome measures
1. Range of movement (flexion, extension, abduction, external rotation and internal rotation) this will be assessed by physiotherapists at 6 weeks, 3 months and 1 year. Measurement will be performed using a goniometer to accurately assess range of movement
2. SF12 score this is a survey form has been shown to yield summary physical and mental health outcome scores
3. Range of movement (flexion, extension, abduction and internal rotation) this will be assessed by physiotherapists at 6 weeks, 6 months and 1 year. Measurement will be performed using a goniometer to accurately assess range of movement
4. Time to union of fracture X-rays will be at taken at 6 weeks and 3 months
5. Return to work post surgery this will be documented at the 1 year follow up appointment
6. Reoperations and complications this will be documented by the clinician at the various outpatient appointments.
Overall trial start date
24/01/2013
Overall trial end date
31/12/2015
Reason abandoned
Participant recruitment issue
Eligibility
Participant inclusion criteria
1. Proximal humeral fractures requiring operative intervention with extramedullary plate fixation (i.e. fractures displaced by 1cm and/or angulated by 45 degrees or more)
2. Age over 18 years of age
3. Patients able to give informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Patients having intraoperative findings of complete Pectoralis major rupture or if operative exposure requires complete Pectoralis major tenotomy. (These patients need to be held in internal rotation with a standard polysling to allow healing of the Pectoralis major tendon)
2. Patients under 18 years of age
3. Patients unable to give informed consent
Recruitment start date
24/01/2013
Recruitment end date
31/12/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Torbay District General Hospital
Torquay
TQ2 7AA
United Kingdom
Sponsor information
Organisation
South Devon Healthcare NHS Foundation Trust (UK)
Sponsor details
R&D Manager
Research and Development Department
Horizon Centre
Torbay District General Hospital
Lawes Bridge
Torquay
TQ2 7AA
United Kingdom
+44 (0)1803 656635
sdhct.research@nhs.net
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Torbay Medical Research Fund (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Protocol in https://online.boneandjoint.org.uk/doi/abs/10.1302/1358-992x.95bsupp_9.swoc2012-031?journalCode=procs