Abstract
Patients using a neutral rotation brace post proximal humerus fracture fixation have improved functional outcome and external rotation of the shoulder compared to patients using a standard polysling.
Patients who have proximal humerus fracture fixation with extramedullary plates and screws have a risk of reduced range of movement especially external rotation. Gerber et al showed that the average external rotation after fixation of proximal humeral fractures was 39 degrees in their patient cohort compared to a normal range of 80–100 degrees. This can lead to reduced function and poor patient related outcomes. Geiger et al showed that in a cohort of 28 patients, poor functional outcome was noted in 39.3% with an average Constant-Murley Score of 57.9.
Current practice is to utilise a polysling holding the shoulder in internal rotation post-shoulder fixation. Patients usually wear the sling for up to 6 weeks. We believe that this increases the risk of adhesion formation with the shoulder in internal rotation in the shoulder joint. Therefore this can cause loss of external rotation in the shoulder joint. We believe that holding the shoulder in a neutral alignment, with a neutral rotation brace post-fixation, will enable an increased rate of external rotation post-operatively thus improving external rotation and functional outcome
There is currently no literature comparing the different slings used post-operatively and we believe that this study would be the first of its kind. It would have a substantial change in the way clinicians manage proximal humeral fractures and will potentially reduce the numbers of re-operations to divide adhesions or perform capsular releases. Secondary benefits include a potential earlier return to full function and work and improved patient satisfaction.
Study proposal: Prospective Randomised Controlled Trial of the neutral rotation brace compared to the standard, currently used, polysling post proximal humerus fracture fixation. No blinding of either participants or clinicians. Three surgeons utilising similar fixation techniques via the deltopectoral approach and using Philos plate fixation (Synthes Ltd.). Standardised post-operative rehabilitation protocol for all patients.
Follow up: clinical review and postal outcomes for 1 year
Primary outcomes: Post operative functional outcome scores (Oxford, DASH, EQL) obtained at 6 weeks, 9 weeks, 3 months and 1 year). These will be compared to scores taken pre-operatively.
Secondary outcomes: Clinical review at 6 weeks, 3 months and 1 year with range of movement measurements. Radiographs also taken at 6 weeks and 3 months to assess union. Patient questionnaire at 1 year (with outcome scores) assessing patient return to work, complications and patient satisfaction
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>18.
Exclusion Criteria: Patients having intra-operative 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).
