Proximal Humeral Fracture
Conditions
Keywords
Proximal humeral fracture, Shoulder, Orthopaedics, Neutral rotation brace, Polysling
Brief summary
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.
Interventions
PROCEDUREOperative procedure to fix proximal humeral
Operative fixation by the shoulder team at Torbay Hospital
DEVICENeutral Rotation Brace
Performed at the end of the surgical procedure at Torbay Hospital
OTHERPhysiotherapy review
Physiotherapy review on day of surgery, and post-surgery at 6 weeks, 3 months and 1 year.
OTHERFunctional outcome forms filled in
OTHERPostal functional outcome scores
Sent to patient at 9 weeks post surgery
OTHERPost-operative Radiographs
Performed at 6 weeks and 3 months at shoulder clinic appointment at Torbay Hospital
Sponsors
Torbay and South Devon NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxford score | 1 Year post surgery | 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 |
| DASH - the Disabilities of the Arm, Shoulder and Hand | 1 year post surgery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Range of movement (flexion, extension, abduction and internal rotation) | 6 weeks, 6 months and 1 year | Conducted by physiotherapists. Measured using a goniometer to accurately assess range of movement |
| Time to union of fracture | 6 weeks and 3 Months | X-Rays taken |
| Range of movement(flexion, extension, abduction, external and internal rotation) | 6 weeks, 3 months and 1 year | Assessed by Physiotherapists. Measurement will be performed using a goniometer to accurately assess range of movement |
| Re-operations and Complications | Throughout 1st year as applicable at outpatient appointments | Documented at various outpatient appointments |
| Return to work post surgery | 1 year follow up | — |
| SF-12 Score | 1 Year post surgery | This survey form has been shown to yield summary physical and mental health outcome scores |
Countries
United Kingdom
Outcome results
None listed