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| Multi-centre randomised trial evaluating surgery for displaced fractures of the proximal humerus |
| Source of record | UK Trials |
| ISRCTN | ISRCTN50850043 |
| Date ISRCTN assigned | 25/03/2008 |
| Local reference number(s) | HTA 06/404/53 |
| Public title | Multi-centre randomised trial evaluating surgery for displaced fractures of the proximal humerus |
| Scientific title | Pragmatic multi-centre randomised trial of surgical versus non-surgical treatment for proximal fracture of the humerus in adults |
| Acronym | PROFHER |
| Disease/condition/study domain | Musculoskeletal trauma of the upper limb |
| Study hypothesis | To assess the effectiveness and cost-effectiveness of surgical versus non-surgical treatment of the majority of displaced proximal humeral fractures in adults. |
| Design/methodology | Multi-centre randomised controlled trial. |
| Research ethics review | York Multi-centre Research Ethics Committee (MREC), approved on 11/03/2007 (ref: 08/H1311/12) |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Aged 16 or above, male and female 2. Presenting to the participating trauma centre within 3 weeks of their injury 3. Radiologically confirmed displaced fracture of the proximal humerus involving the surgical neck 4. Surgeon would consider surgical treatment for the fracture |
| Participants - exclusion criteria | 1. Open fracture 2. Cognitive impairment that would preclude participation 3. Co-morbidities precluding surgery/ anaesthesia 4. Clear indication for surgery such as severe soft-tissue compromise requiring surgery/ emergency treatment 5. Multiple injuries: Same limb fractures, other upper limb fractures 6. Pathological fractures (other than osteoporotic) 7. Terminal illness 8. Participant not resident in trauma-centre catchment area |
| Patient information material | |
| Anticipated start date | 01/10/2008 |
| Anticipated end date | 30/09/2012 |
| Status of trial | Ongoing |
| Target number of participants | 250 |
| Interventions | Participants will be randomised to one of two basic treatment interventions: 1. Surgery (fixation or joint replacement) 2. Non-surgical management (sling immobilisation) |
| Primary outcome measure(s) | Oxford Shoulder Score (12-item condition-specific questionnaire providing a total score based on the person's subjective assessment of pain and activities of daily living impairment) assessed at 6, 12 and 24 months via postal questionnaire. |
| Secondary outcome measure(s) | 1. The 12-item short form health survey (SF-12) and Euroqol (EQ-5D) for general health status data (at 6, 12 and 24 months) 2. Complications, including surgical complications (wound infection, implant failure, shoulder dislocation, septicaemia). Duration of follow-up: 2 years 3. Early medical complications, i.e. chest infection, confirmed myocardial infarction or stroke, treated deep vein thrombosis and pulmonary embolism. 4. Mortality. Duration of follow-up: 2 years 5. Subsequent referral for operation or substantive treatment. Duration of follow-up: 2 years 6. Data for economic evaluation: NHS and societal costs |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Sponsor name | University of Teesside (UK) |
| Sponsor details | - Middlesbrough United Kingdom TS1 3BA |
| Sponsor website | http://www.tees.ac.uk |
| Contact name | Mr Amar Rangan |
| Contact details | Consultant Orthopaedic Surgeon The James Cook University Hospital Marton Road Middlesbrough United Kingdom TS4 3BW |
| Contact telephone | +44 1642 854380 |
| Contact fax | +44 1642 854375 |
| Contact email | amar.rangan@stees.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN50850043 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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