Date Published: July 18, 2019
Publisher: Public Library of Science
Author(s): Antti P. Launonen, Bakir O. Sumrein, Aleksi Reito, Vesa Lepola, Juha Paloneva, Kenneth B. Jonsson, Olof Wolf, Peter Ström, Hans E. Berg, Li Felländer-Tsai, Karl-Åke Jansson, Daniel Fell, Inger Mechlenburg, Kaj Døssing, Helle Østergaard, Aare Märtson, Minna K. Laitinen, Ville M. Mattila, Helen Handoll
Abstract: BackgroundAlthough 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 findingsThe 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.ConclusionsThis 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.Trial registrationClinicalTrials.gov NCT01246167.
Partial Text: Proximal humerus fractures (PHFs) are among the most common fractures in the older adult population [1,2]. In a Swedish nationwide study, the person-based incidence of PHF in adults was 175 per 100,000 person-years in women and 68 per 100,000 person-years in men . The risk for having a PHF increases with age, especially after the age of 60 years [3,4].
Between February 2011 and April 2016, a total of 88 patients with PHF with surgical neck involvement were randomly assigned to undergo either operative treatment with a locking plate or non-operative treatment. In total, 44 patients were assigned to undergo operative treatment with a locking plate and 44 to non-operative treatment (Fig 1). The characteristics of the study population at the time of enrollment are shown in Table 1.
The present investigation is, to our knowledge, the first prospective randomized controlled trial to compare non-operative and operative treatment with Philos plate in patients aged 60 years or older with displaced 2-part PHFs. This trial provides no evidence that surgery is superior to non-operative treatment in 2-year follow-up. Furthermore, we found no clinically or statistically significant between-group differences in any of the outcomes measured, including DASH (our primary outcome measure), CS, OSS, EQ-5D, 15D, VAS, complications, and mortality.