Return of function and external rotation post proximal humerus fracture fixation with neutral rotation brace

ISRCTN	ISRCTN38563880
DOI	https://doi.org/10.1186/ISRCTN38563880
ClinicalTrials.gov (NCT)	NCT02073695
Protocol serial number	13/01/049
Sponsor	South Devon Healthcare NHS Foundation Trust (UK)
Funder	Torbay Medical Research Fund (UK)

Submission date: 15/04/2014
Registration date: 13/05/2014
Last edited: 08/03/2018

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Ms Veronica Conboy
Scientific

Consultant in Trauma and Orthopaedics
Torbay District General Hospital
Lawes Bridge
Torquay
TQ2 7AA
United Kingdom

Phone	+44 (0)1803 656635
Email	veronica.conboy@nhs.net

Study information

Primary study design	Interventional
Study design	Single-centre randomised interventional trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Return Of funcTion And exTErnal rotation post proximal humerus fracture fixation with neutral rotation brace: a randomised controlled trial
Study acronym	ROTATE
Study objectives	Using a neutral rotation brace will help improve patients external shoulder rotation and improve functional outcome.
Ethics approval(s)	NRES Committee South West - Central Bristol, 22/01/2013, ref: 12/SW/0334
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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.
Completion date	31/12/2015
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	100
Key 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
Key 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
Date of first enrolment	24/01/2013
Date of final enrolment	31/12/2015

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Torbay District General Hospital

Torquay
TQ2 7AA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	Protocol	21/02/2018		Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

08/03/2018: Protocol publication reference added.
26/01/2018: The trial stopped due to recruitment difficulties.