NIHR Signal Surgery is no more effective than a sling for misaligned shoulder fractures

Published on 11 March 2015

This NIHR funded trial showed that conservative treatment involving a sling was as effective as surgery for treating people with displaced fractures of the upper arm. A linked economic analysis showed that surgery was not cost-effective. These kinds of shoulder fractures are common and disabling, and mainly affect people over 65. Slings are already used as the main treatment for undisplaced fractures. Surgical treatment of displaced fractures is becoming more common. This evidence could help reverse the trend, reducing complications to patients and costs to the NHS.

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Why was this study needed?

Proximal humeral fractures are common, accounting for 5-6% of all adult bone fractures. Half of these fractures are displaced. Most people with this type of fracture are over 65 and have fragile bones from osteoporosis and the number affected in this age-group is increasing. Surgery is expensive and involves more time in hospital than conservative treatment, with added risks of complication such as infection. A 2012 Cochrane review of 23 studies, and a 2014 meta-analysis of six studies, found that there was insufficient evidence in favour of either surgery or conservative treatment. The NIHR funded this trial to provide clearer evidence on the issue.

What did this study do?

PROFHER was a randomised controlled trial involving 250 people, average age 66, at 32 UK hospitals. It compared surgical and nonsurgical treatment for adults with displaced fractures of the neck of the humerus. People with shoulder dislocation or with multiple injuries were excluded. Participants were assigned to have surgical treatment or the affected arm immobilised in a sling. Both groups received physiotherapy. During two years of follow-up, patients reported their shoulder pain, its function, and their quality of life.

The trial was sufficiently large and run in NHS hospitals. All surgical and conservative treatments used followed good practice. The results should therefore be considered reliable and relevant to UK practice.

What did it find?

  • Over two years follow-up there was no difference in shoulder pain or function scores between people who had shoulder surgery or a sling (the surgery group averaged over the two years 39.07, and the sling group 38.32, on the 48 point "Oxford Shoulder Score" scale)
  • There remained no difference in the results when analysed by type of fracture, hospital where treated, patient age or smoking status
  • There was no difference in quality of life over two years

What does current guidance say on this issue?

There are currently no UK guidelines that give recommendations on how to treat fractures of the neck of the humerus. Consequently there is likely to be wide variation in practice between hospitals.

What are the implications?

The evidence from the PROFHER trial shows that a sling was as effective as surgery for treating displaced fractures of the proximal humerus.

A linked cost-effectiveness analysis showed that after two years the cost of surgery was, on average, £1780.73 more per patient than the cost of using a sling. Using a sling is likely to be safer, causing fewer complications, especially in older people.

Based on the evidence, commissioners and clinicians could consider reducing the numbers of surgical interventions for this condition.

Citation

Rangan A, Handoll H, Brealey S, Jefferson L, Keding A, Martin BC, et al. Surgical vs Nonsurgical Treatment of Adults With Displaced Fractures of the Proximal Humerus: The PROFHER Randomized Clinical Trial. JAMA. 2015;313(10):1037-47. This project was funded by the National Institute for Health Research HTA Programme (project number 06/404/53).

Bibliography

Bell J-E, Leung BC, Spratt KF, et al. Trends and variation in incidence, surgical treatment, and repeat surgery of proximal humeral fractures in the elderly. The Journal of Bone & Joint Surgery. 2011;93(2):121-31.

Handoll HHG, Ollivere BJ, Rollins KE. Interventions for treating proximal humeral fractures in adults. Cochrane Database of Systematic Reviews 2012,(12): CD000434

Handoll H, Brealey S, Rangan A, et al. 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. Health Technol Assess. 2015 Mar;19(24):1-280.

Isis Innovation Ltd. The Oxford Shoulder Score (OSS). (website)

Neer II, CS. Displaced proximal humeral fractures. Part I. Classification and evaluation. J Bone Joint Surg Am. 1970;52:1077-1089.

Neer II, CS. Displaced proximal humeral fractures. Treatment of three-part and four-part displacement. J Bone Joint Surg Am. 1970;52:1090-1103.

Zhi M, Lihai Z, Licheng Z, et al. Operative versus nonoperative treatment in complex proximal humeral fractures. Orthopedics. 2014;37(5):e410-e9.

Why was this study needed?

Proximal humeral fractures are common, accounting for 5-6% of all adult bone fractures. Half of these fractures are displaced. Most people with this type of fracture are over 65 and have fragile bones from osteoporosis and the number affected in this age-group is increasing. Surgery is expensive and involves more time in hospital than conservative treatment, with added risks of complication such as infection. A 2012 Cochrane review of 23 studies, and a 2014 meta-analysis of six studies, found that there was insufficient evidence in favour of either surgery or conservative treatment. The NIHR funded this trial to provide clearer evidence on the issue.

What did this study do?

PROFHER was a randomised controlled trial involving 250 people, average age 66, at 32 UK hospitals. It compared surgical and nonsurgical treatment for adults with displaced fractures of the neck of the humerus. People with shoulder dislocation or with multiple injuries were excluded. Participants were assigned to have surgical treatment or the affected arm immobilised in a sling. Both groups received physiotherapy. During two years of follow-up, patients reported their shoulder pain, its function, and their quality of life.

The trial was sufficiently large and run in NHS hospitals. All surgical and conservative treatments used followed good practice. The results should therefore be considered reliable and relevant to UK practice.

What did it find?

  • Over two years follow-up there was no difference in shoulder pain or function scores between people who had shoulder surgery or a sling (the surgery group averaged over the two years 39.07, and the sling group 38.32, on the 48 point "Oxford Shoulder Score" scale)
  • There remained no difference in the results when analysed by type of fracture, hospital where treated, patient age or smoking status
  • There was no difference in quality of life over two years

What does current guidance say on this issue?

There are currently no UK guidelines that give recommendations on how to treat fractures of the neck of the humerus. Consequently there is likely to be wide variation in practice between hospitals.

What are the implications?

The evidence from the PROFHER trial shows that a sling was as effective as surgery for treating displaced fractures of the proximal humerus.

A linked cost-effectiveness analysis showed that after two years the cost of surgery was, on average, £1780.73 more per patient than the cost of using a sling. Using a sling is likely to be safer, causing fewer complications, especially in older people.

Based on the evidence, commissioners and clinicians could consider reducing the numbers of surgical interventions for this condition.

Citation

Rangan A, Handoll H, Brealey S, Jefferson L, Keding A, Martin BC, et al. Surgical vs Nonsurgical Treatment of Adults With Displaced Fractures of the Proximal Humerus: The PROFHER Randomized Clinical Trial. JAMA. 2015;313(10):1037-47. This project was funded by the National Institute for Health Research HTA Programme (project number 06/404/53).

Bibliography

Bell J-E, Leung BC, Spratt KF, et al. Trends and variation in incidence, surgical treatment, and repeat surgery of proximal humeral fractures in the elderly. The Journal of Bone & Joint Surgery. 2011;93(2):121-31.

Handoll HHG, Ollivere BJ, Rollins KE. Interventions for treating proximal humeral fractures in adults. Cochrane Database of Systematic Reviews 2012,(12): CD000434

Handoll H, Brealey S, Rangan A, et al. 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. Health Technol Assess. 2015 Mar;19(24):1-280.

Isis Innovation Ltd. The Oxford Shoulder Score (OSS). (website)

Neer II, CS. Displaced proximal humeral fractures. Part I. Classification and evaluation. J Bone Joint Surg Am. 1970;52:1077-1089.

Neer II, CS. Displaced proximal humeral fractures. Treatment of three-part and four-part displacement. J Bone Joint Surg Am. 1970;52:1090-1103.

Zhi M, Lihai Z, Licheng Z, et al. Operative versus nonoperative treatment in complex proximal humeral fractures. Orthopedics. 2014;37(5):e410-e9.

Surgical vs nonsurgical treatment of adults with displaced fractures of the proximal humerus: the PROFHER randomized clinical trial

Published on 11 March 2015

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

Jama Volume 313 , 2015

IMPORTANCE: The need for surgery for the majority of patients with displaced proximal humeral fractures is unclear, but its use is increasing. OBJECTIVE: To evaluate the clinical effectiveness of surgical vs nonsurgical treatment for adults with displaced fractures of the proximal humerus involving the surgical neck. DESIGN, SETTING, AND PARTICIPANTS: A pragmatic, multicenter, parallel-group, randomized clinical trial, the Proximal Fracture of the Humerus Evaluation by Randomization (PROFHER) trial, recruited 250 patients aged 16 years or older (mean age, 66 years [range, 24-92 years]; 192 [77%] were female; and 249 [99.6%] were white) who presented at the orthopedic departments of 32 acute UK National Health Service hospitals between September 2008 and April 2011 within 3 weeks after sustaining a displaced fracture of the proximal humerus involving the surgical neck. Patients were followed up for 2 years (up to April 2013) and 215 had complete follow-up data. The data for 231 patients (114 in surgical group and 117 in nonsurgical group) were included in the primary analysis. INTERVENTIONS: Fracture fixation or humeral head replacement were performed by surgeons experienced in these techniques. Nonsurgical treatment was sling immobilization. Standardized outpatient and community-based rehabilitation was provided to both groups. MAIN OUTCOMES AND MEASURES: Primary outcome was the Oxford Shoulder Score (range, 0-48; higher scores indicate better outcomes) assessed during a 2-year period, with assessment and data collection at 6, 12, and 24 months. Sample size was based on a minimal clinically important difference of 5 points for the Oxford Shoulder Score. Secondary outcomes were the Short-Form 12 (SF-12), complications, subsequent therapy, and mortality. RESULTS: There was no significant mean treatment group difference in the Oxford Shoulder Score averaged over 2 years (39.07 points for the surgical group vs 38.32 points for the nonsurgical group; difference of 0.75 points [95% CI, -1.33 to 2.84 points]; P = .48) or at individual time points. There were also no significant between-group differences over 2 years in the mean SF-12 physical component score (surgical group: 1.77 points higher [95% CI, -0.84 to 4.39 points]; P = .18); the mean SF-12 mental component score (surgical group: 1.28 points lower [95% CI, -3.80 to 1.23 points]; P = .32); complications related to surgery or shoulder fracture (30 patients in surgical group vs 23 patients in nonsurgical group; P = .28), requiring secondary surgery to the shoulder (11 patients in both groups), and increased or new shoulder-related therapy (7 patients vs 4 patients, respectively; P = .58); and mortality (9 patients vs 5 patients; P = .27). Ten medical complications (2 cardiovascular events, 2 respiratory events, 2 gastrointestinal events, and 4 others) occurred in the surgical group during the postoperative hospital stay. CONCLUSIONS AND RELEVANCE: Among patients with displaced proximal humeral fractures involving the surgical neck, there was no significant difference between surgical treatment compared with nonsurgical treatment in patient-reported clinical outcomes over 2 years following fracture occurrence. These results do not support the trend of increased surgery for patients with displaced fractures of the proximal humerus. TRIAL REGISTRATION: isrctn.com Identifier: ISRCTN50850043.

The PROFHER trial used the Neer Classification of displaced proximal humeral fractures. It is based on the number of fractured parts of the humerus (up to 4), and the displacement (measured by the angle or distance between the fractured parts). Neer counted the fracture as displaced if the break separation exceeded 1cm or the angle was at least 45 degrees. The Neer classification and the AO classification of proximal humeral fractures are together the most frequently used classification tools for this type of injury.

Author commentary

This rigorous and pragmatic trial is the largest randomised trial to date on proximal humeral fractures, addressing a key uncertainty in contemporaneous clinical practice. Prior to this trial, it was not clear whether current surgical interventions resulted in better outcomes for the majority of displaced proximal humeral fractures in adults when compared with standard non-surgical treatment. Since the publication of this trial, there are already signs of a reversal in the recent trend to increased use of surgery for these fractures. In addition to avoiding unnecessary surgery, this change in practice is likely to lead to considerable cost savings for the NHS.

Professor Amar Rangan, Clinical professor of trauma and orthopaedic surgery, James Cook University Hospital & Dr Helen Handoll, Senior Lecturer and Research Fellow, Teesside University