Multi-centre randomised trial evaluating surgery for displaced fractures of the proximal humerus

Conditions

Musculoskeletal trauma of the upper limb Injury, Occupational Diseases, Poisoning Fractures of the proximal humerus

Ada Keding, Helen HG Handoll, Stephen Brealey, Laura Jefferson, Catherine Hewitt et al. (8 authors)

Trials2019-09-1813 citations

10.1186/s13063-019-3631-x

Surgical vs Nonsurgical Treatment of Adults With Displaced Fractures of the Proximal Humerus

Amar Rangan, Helen HG Handoll, Stephen Brealey, Laura Jefferson, Ada Keding et al. (10 authors)

JAMA2015-03-10523 citations

10.1001/jama.2015.1629

The ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation) trial - a pragmatic multicentre randomised controlled trial evaluating the clinical effectiveness and cost-effectiveness of surgical compared with non-surgical treatment for proximal fracture of the humerus in adults.

Handoll H, Brealey S, Rangan A, Keding A, Corbacho B, Jefferson L, Chuang LH, Goodchild L, Hewitt C, Torgerson D.

2015-03-0198 citations

10.3310/hta19240

Protocol for the ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation) trial: a pragmatic multi-centre randomised controlled trial of surgical versus non-surgical treatment for proximal fracture of the humerus in adults.

Handoll H, Brealey S, Rangan A, Torgerson D, Dennis L, Armstrong A, Chuang LH, Cross B, Dumville J, Gardner S, Goodchild L, Hamilton S, Hewitt C, Madhok R, Maffulli N, Micklewright L, Wadsworth V, Wallace A, Williams J, Worthy G.

2009-11-1636 citations

10.1186/1471-2474-10-140

Interventions

Interventions as of 18/10/2016: After obtaining informed consent and key baseline information, research associates will randomly allocate patients to surgical or non-surgical treatment using an indepe

a basic treatment protocol to guide physiotherapy

and promotion of home exercises. Rehabilitation care will be provided by physiotherapists in inpatient, outpatient, and community settings. Participants in both groups complete a range of questionnai

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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 and 3, 4 and 5 years via postal questionnaire.	—

Secondary

Measure	Time frame
1. General health status is measured using The 12-item short form health survey (SF-12) at 6, 12 and 24 months and Euroqol (EQ-5D) at 3, 6, 12 and 24 months and 3, 4 and 5 years 2. Complications, including surgical complications (wound infection, implant failure, shoulder dislocation, septicaemia) are assessed via medical record review at the end of an in-patient episode at the start of the trial and at 1 and 2 year hospital follow-up 3. Early medical complications, i.e. chest infection, confirmed myocardial infarction or stroke, treated deep vein thrombosis and pulmonary embolism are assessed via medical record review at the end of an in-patient episode at the start of the trial and other medical complications at 1 and 2 year hospital follow-up 4. Mortality rate is assessed via medical review continuously for 2 years 5. Subsequent referral for operation or substantive treatment is assessed via medical record review at 1 and 2 year hospital follow-up and then at 3, 4 and 5 year follow ups via postal questionnaire 6. NHS and societal costs are collected at 3, 6, 12 and 24 months via postal questionnaire and hospital forms: surgical form, physiotherapy form, inpatient episode form and 1 and 2 year hospital follow-up forms	—

Measure

Time frame

1. General health status is measured using The 12-item short form health survey (SF-12) at 6, 12 and 24 months and Euroqol (EQ-5D) at 3, 6, 12 and 24 months and 3, 4 and 5 years 2. Complications, including surgical complications (wound infection, implant failure, shoulder dislocation, septicaemia) are assessed via medical record review at the end of an in-patient episode at the start of the trial and at 1 and 2 year hospital follow-up 3. Early medical complications, i.e. chest infection, confirmed myocardial infarction or stroke, treated deep vein thrombosis and pulmonary embolism are assessed via medical record review at the end of an in-patient episode at the start of the trial and other medical complications at 1 and 2 year hospital follow-up 4. Mortality rate is assessed via medical review continuously for 2 years 5. Subsequent referral for operation or substantive treatment is assessed via medical record review at 1 and 2 year hospital follow-up and then at 3, 4 and 5 year follow ups via postal questionnaire 6. NHS and societal costs are collected at 3, 6, 12 and 24 months via postal questionnaire and hospital forms: surgical form, physiotherapy form, inpatient episode form and 1 and 2 year hospital follow-up forms

—

Countries

England, United Kingdom

Outcome results

None listed