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Operative versus non-operative treatment for 2-part proximal humerus fracture: A multicenter randomized controlled trial

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Date
2019
Author(s)
Launonen, AP
Sumrein, BO
Reito, A
Lepola, V
Paloneva, J
Jonsson, KB
Wolf, O
Ström, P
Berg, HE
Felländer-Tsai, L
Jansson, K
Fell, D
Mechlenburg, I
Døssing, K
Østergaard, H
Märtson, A
Laitinen, MK
Mattila, VM
Unique identifier
10.1371/journal.pmed.1002855
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Citation
Launonen, AP. Sumrein, BO. Reito, A. Lepola, V. Paloneva, J. Jonsson, KB. Wolf, O. Ström, P. Berg, HE. Felländer-Tsai, L. Jansson, K. Fell, D. Mechlenburg, I. Døssing, K. Østergaard, H. Märtson, A. Laitinen, MK. Mattila, VM. (2019). Operative versus non-operative treatment for 2-part proximal humerus fracture: A multicenter randomized controlled trial.  PLoS medicine, 16 (7) , e1002855. 10.1371/journal.pmed.1002855.
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© 2019 Authors
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CC BY http://creativecommons.org/licenses/by/4.0/
Abstract

Background
Although increasingly used, the benefit of surgical treatment of displaced 2-part proximal humerus fractures has not been proven. This trial evaluates the clinical effectiveness of surgery with locking plate compared with non-operative treatment for these fractures.

Methods and findings
The NITEP group conducted a superiority, assessor-blinded, multicenter randomized trial in 6 hospitals in Finland, Estonia, Sweden, and Denmark. Eighty-eight patients aged 60 years or older with displaced (more than 1 cm or 45 degrees) 2-part surgical or anatomical neck proximal humerus fracture were randomly assigned in a 1:1 ratio to undergo either operative treatment with a locking plate or non-operative treatment. The mean age of patients was 72 years in the non-operative group and 73 years in the operative group, with a female sex distribution of 95% and 87%, respectively. Patients were recruited between February 2011 and April 2016. The primary outcome measure was Disabilities of Arm, Shoulder, and Hand (DASH) score at 2-year follow-up. Secondary outcomes included Constant–Murley score, the visual analogue scale for pain, the quality of life questionnaire 15D, EuroQol Group’s 5-dimension self-reported questionnaire EQ-5D, the Oxford Shoulder Score, and complications. The mean DASH score (0 best, 100 worst) at 2 years was 18.5 points for the operative treatment group and 17.4 points for the non-operative group (mean difference 1.1 [95% CI −7.8 to 9.4], p = 0.81). At 2 years, there were no statistically or clinically significant between-group differences in any of the outcome measures. All 3 complications resulting in secondary surgery occurred in the operative group. The lack of blinding in patient-reported outcome assessment is a limitation of the study. Our assessor physiotherapists were, however, blinded.

Conclusions
This trial found no significant difference in clinical outcomes at 2 years between surgery and non-operative treatment in patients 60 years of age or older with displaced 2-part fractures of the proximal humerus. These results suggest that the current practice of performing surgery on the majority of displaced proximal 2-part fractures of the humerus in older adults may not be beneficial.

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https://erepo.uef.fi/handle/123456789/8206
Link to the original item
https://doi.org/10.1371/journal.pmed.1002855
Publisher
Public Library of Science
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