Return of Function and External Rotation Post Proximal Humerus Fracture Fixation With Neutral Rotation Brace

Study Overview
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Brief Summary
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Research question: Do patients using a neutral rotation brace post surgery have improved functional outcome and external rotation of the shoulder compared to current best practice using a polysling holding the proximal humerus in internal rotation? Primary objectives: To compare post-operative functional outcome scores obtained at 6 weeks, 9 weeks, 3 months and 1 year. (Scores at 6 weeks and 3 months in clinical review and postal scores at 9 weeks and 1 year) between patients held in neutral versus current standard rotation. These will be compared to scores taken pre-operatively. Benefits: There may be no extra benefits to patients from this trial however the results from the trial will help improve treatment for future patients at this hospital, and others across the country. Risks/disadvantages: The operation is the same in both groups studied, the study is investigating the use of the two different slings. The post-operative treatment is also the same, and all patients on the trial will receive the same amount of physiotherapy. It isn't anticipated that there will be any additional risk from this trial.

Official Title
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Return of Function and External Rotation Post Proximal Humerus Fracture Fixation With Neutral Rotation Brace

Conditions
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Proximal Humeral Fracture

Intervention / Treatment
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* Procedure: Operative procedure to fix proximal humeral
* Device: Neutral Rotation Brace
* Other: Physiotherapy review
* Other: Functional outcome forms filled in
* Other: Postal functional outcome scores
* Other: Post-operative Radiographs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Proximal humeral fractures requiring operative intervention with extramedullary plate fixation (i.e. fractures displaced by 1cm and/or angulated by 45 degrees or more) Age over 18 years of age Patient able to give informed consent Exclusion Criteria: Patients having intra-operative findings to 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) Patients under 18 years of age Patients unable to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Neutral Rotation Brace<br>Neutral Rotation Brace | Procedure: Operative procedure to fix proximal humeral<br>* Operative fixation by the shoulder team at Torbay Hospital<br>Device: Neutral Rotation Brace<br>* Performed at the end of the surgical procedure at Torbay Hospital<br>Other: Physiotherapy review<br>* Physiotherapy review on day of surgery, and post-surgery at 6 weeks, 3 months and 1 year.<br>Other: Functional outcome forms filled in<br> <br> * Other names: SF-12;Other: Postal functional outcome scores<br>* Sent to patient at 9 weeks post surgery<br>Other: Post-operative Radiographs<br>* Performed at 6 weeks and 3 months at shoulder clinic appointment at Torbay Hospital<br>|
| Other: Standard polysling (Current practice)<br>Standard polysling (Current practice) | Procedure: Operative procedure to fix proximal humeral<br>* Operative fixation by the shoulder team at Torbay Hospital<br>Device: Neutral Rotation Brace<br>* Performed at the end of the surgical procedure at Torbay Hospital<br>Other: Physiotherapy review<br>* Physiotherapy review on day of surgery, and post-surgery at 6 weeks, 3 months and 1 year.<br>Other: Functional outcome forms filled in<br> <br> * Other names: SF-12;Other: Postal functional outcome scores<br>* Sent to patient at 9 weeks post surgery<br>Other: Post-operative Radiographs<br>* Performed at 6 weeks and 3 months at shoulder clinic appointment at Torbay Hospital<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford score | 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 of 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 | 1 Year post surgery | 
| DASH - 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 and psychological function | 1 year post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of movement(flexion, extension, abduction, external and internal rotation) | Assessed by Physiotherapists. Measurement will be performed using a goniometer to accurately assess range of movement | 6 weeks, 3 months and 1 year | 
| SF-12 Score | This survey form has been shown to yield summary physical and mental health outcome scores | 1 Year post surgery | 
| Range of movement (flexion, extension, abduction and internal rotation) | Conducted by physiotherapists. Measured using a goniometer to accurately assess range of movement | 6 weeks, 6 months and 1 year | 
| Time to union of fracture | X-Rays taken | 6 weeks and 3 Months | 
| Return to work post surgery |  | 1 year follow up | 
| Re-operations and Complications | Documented at various outpatient appointments | Throughout 1st year as applicable at outpatient appointments | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polysling, Neutral rotation brace, Proximal humeral fracture, Shoulder, Orthopaedics