Most orthopaedic surgeons have met patients with poor shoulder function after a proximal humerus fracture, and many of us have thought: if I’ve only done the other thing I was thinking of…. Unfortunately the outcome seems to be independent of what we do, at least according to Launonen et al’s meta-analysis and Rangan et al’s recent RCT on 250 patients.
Patient selection
Rangan et al. recruited from 32 centers in UK patients with acute proximal humerus fractures (< 3 weeks), above 16 years of age with more than 1 cm displacement or 45 degree angulation (Neers criteria). They excluded patient with cognitive dysfunction, multiple upper limb fractures and a few other criterias.
Interesting to note is that hey screened 1250 patients from 33 hospitals during almost 3 years. Compared to our clinic, this is a surprising small number of patients. This could be suggestive of a lack of proper inclusion protocols at the participating hospitals.
Randomization
They had a proper randomization procedure with random block size, and stratification for tuberosity involvment. There was some crossover between the groups, 8 patients in the surgical group changed their mind while 2 in the non-surgical group received surgery. Similarly there was a slightly higher rate of missing data for the surgical group in the analysis at the end, but they adressed the missing data with a multiple imputation procedure and it should have a limited impact on the interpretation.
Interventions
In the surgery group the patients received the surgery that that particular surgeon was most familiar with, in 80% of the cases patients this was a locking plate construct and only a fraction was operated with a hemiarthroplasty. The control group were treated with standard sling and physiotherapy.
Results
The primary outcome, Oxford Shoulder Score, was slightly better at 6 months, but did not differ at 12 months and later. The same thing applied to health related quality of life (SF-12 ). I can recommend the figures that beautifully show how the two groups line up after 12 months.
Final thoughts
The methodology is outstanding in this article and the findings are supported by the recent meta-analyses performed by Launonen et al. It is frustrating that despite this injury being common and associated with poor non-surgical outcomes, we can’t help these patients with surgery.
Despite the high quality of the study, it is important to recognize that:
- the results don’t necessarily apply to all included groups, e.g. a few patients were below 30 (average age was 66), suggesting that these could not contribute that much to the result.
- the supplement suggests that half of the patients had a 2-fragment fracture and are perhaps not the target population of intervention at our hospital.
- the patients that were not eligible are only vaguely described. It would be interesting to know if 2-part fractures without bone contact were included, this as many of us believe they need surgery and should have a strong signal in favor of surgery.
I certainly hope that this controversy spurs more into performing multi-center studies on the subject, hopefully then with a higher degree of center participation. Unfortunately, I doubt that this is possible without a strong financial incentive.
- Rangan A, Handoll H, Brealey S, and et al, “Surgical vs nonsurgical treatment of adults with displaced fractures of the proximal humerus: The profher randomized clinical trial,” JAMA, vol. 313, no. 10, pp. 1037–1047, Mar. 2015.
- A. P. Launonen, V. Lepola, T. Flinkkilä, M. Laitinen, M. Paavola, and A. Malmivaara, “Treatment of proximal humerus fractures in the elderly,” Acta Orthopaedica, vol. 86, no. 3, pp. 280–285, May 2015.
Coming across this article made my day and have printed it out to show my colleges.