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Operative versus non-operative treatment for 2-part proximal humerus fracture: A multicenter randomized controlled trial
Univ Tampere, Fac Med & Hlth Technol, Tampere, Finland;Tampere Univ Hosp, Tampere, Finland.
Univ Tampere, Fac Med & Hlth Technol, Tampere, Finland;Tampere Univ Hosp, Tampere, Finland.
Cent Finland Cent Hosp, Dept Orthopaed, Jyvaskyla, Finland.ORCID iD: 0000-0002-6903-6461
Univ Tampere, Fac Med & Hlth Technol, Tampere, Finland;Tampere Univ Hosp, Tampere, Finland.
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2019 (English)In: PLoS Medicine, ISSN 1549-1277, E-ISSN 1549-1676, Vol. 16, no 7, article id e1002855Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
2019. Vol. 16, no 7, article id e1002855
National Category
Orthopaedics
Identifiers
URN: urn:nbn:se:uu:diva-393140DOI: 10.1371/journal.pmed.1002855ISI: 000478681800013PubMedID: 31318863OAI: oai:DiVA.org:uu-393140DiVA, id: diva2:1353405
Available from: 2019-09-23 Created: 2019-09-23 Last updated: 2019-09-23Bibliographically approved

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