Three and four part proximal humeral fractures Injury, Occupational Diseases, Poisoning Fracture of shoulder and upper arm
Conditions
Interventions
The clinical care team will assess potential patient eligibility, and a routine x-ray will be taken to confirm a three or four part fracture. Patients who agree to take part will receive one of the th
Sponsors
South Tees Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
65 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Adult patients aged 65 years or over 2. Radiographically confirmed acute three-part (including surgical neck) or four-part displaced fracture of the proximal humerus (Neer Classification) including head-splitting fractures of the humeral head and fracture dislocations 3. Trial interventions can be provided within 5 weeks of injury 4. Patient is deemed by the clinical care team to be fit for surgery 5. Able to provide full informed consent
Exclusion criteria
Exclusion criteria: 1. Patients who are unable to adhere to trial procedures or complete questionnaires 2. Polytrauma – where one or more additional fractures, which may affect the outcome measures for the trial, are present or other body-systems are affected 3. Open fractures or fractures where there is severe soft tissue compromise requiring urgent surgery 4. Pathological (other than osteoporotic) fractures 5. Presence of axillary nerve palsy (given that this results in a weakening of the deltoid muscle, upon which the shoulder relies for function)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain and impairment impact on daily living activities, measured using the Oxford Shoulder Score at baseline, 6 months, 1 year and 2 years post randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life measured using EQ-5D-5L at baseline, 6 months, 1 year and 2 years post randomisation 2. Pain measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference at baseline, 6 months, 1 year and 2 years post randomisation 3. Pain measured using a visual analogue pain scale at baseline, 6 months, 1 year and 2 years post randomisation 4. Range of shoulder motion measured at discharge from physiotherapy and independently assessed at 6 months post randomisation (i.e. not by the treating surgeon) 5. Healing and implant position using AP and Axillary (and scapular Y view if available) X-rays taken at 6 months post-surgery 6. Further procedures and complications recorded by clinicians at 6 months, 1 year and 2 years post randomisation 7. Grip strength to assess frailty and as a predictor of morbidity and mortality, measured at baseline 8. Physiotherapy requirements and use (including time to start of physiotherapy; number of sessions; modalities used; and duration of rehabilitation) collected during the trial | — |
Countries
England, United Kingdom
Contacts
Public ContactCatherine Arundel
Outcome results
None listed