Surgery with locking plate or hemiarthroplasty versus nonoperative treatment of 3-4-part proximal humerus fractures in older patients (NITEP): An open-label randomized trial

Background Proximal humerus fractures (PHFs) are common fractures, especially in older female patients. These fractures are commonly treated surgically, but the consensus on the best treatment is still lacking. Methods and findings The primary aim of this multicenter, randomized 3-arm superiority, open-label trial was to assess the results of nonoperative treatment and operative treatment either with locking plate (LP) or hemiarthroplasty (HA) of 3- and 4-part PHF with the primary outcome of Disabilities of the Arm, Shoulder, and Hand (DASH) at 2-year follow-up. Between February 2011 and December 2019, 160 patients 60 years and older with 3and 4-part PHFs were randomly assigned in 1:1:1 fashion in block size of 10 to undergo nonoperative treatment (control) or operative intervention with LP or HA. In total, 54 patients were assigned to the nonoperative group, 52 to the LP group, and 54 to the HA group. Five patients assigned to the LP group were reassigned to the HA group perioperatively due to high comminution, and all of these patients had 4-part fractures. In the intention-to-treat analysis, there were 42 patients in the nonoperative group, 44 in the LP group, and 37 in the HA group. The outcome assessors were blinded to the study group. The mean DASH score at 2-year follow-up was 30.4 (standard error (SE) 3.25), 31.4 (SE 3.11), and 26.6 (SE 3.23) points for the nonoperative, LP, and HA groups, respectively. At 2 years, the between-group differences were 1.07 points (95% CI [-9.5,11.7]; p = 0.97) between nonoperative and LP, 3.78 points (95% CI [-7.0,14.6]; p = 0.69) between nonoperative and HA, and 4.84 points (95% CI [- 5.7,15.4]; p = 0.53) between LP and HA. No significant differences in primary or secondary outcomes were seen in stratified age groups (60 to 70 years and 71 years and over). At 2 years, we found 30 complications (3/52, 5.8% in nonoperative; 22/49, 45% in LP; and 5/49, 10% in HA group, p = 0.0004) and 16 severe pain-related adverse events. There was a revision rate of 22% in the LP group. The limitation of the trial was that the recruitment period was longer than expected due to a high number of exclusions after the assessment of eligibility and a larger exclusion rate than anticipated toward the end of the trial. Therefore, the trial was ended prematurely. Conclusions In this study, no benefit was observed between operative treatment with LP or HA and nonoperative treatment in displaced 3- and 4-part PHFs in patients aged 60 years and older. Further, we observed a high rate of complications related to operative treatments. Author summary Why was this study done? Proximal humerus fractures (PHFs) are among the most common fractures in older adults. The risks for suffering a PHF increase with age, especially after the age of 60 years. Nonoperative treatment of non-displaced PHF is uniformly approved, but the treatment of displaced 3- and 4-part PHF remains controversial. Recently, several studies have reported a significant increase in the surgical treatment of the PHF, mainly due to the introduction of locking plates (LPs) suitable for treating osteoporotic bone. In this study, we investigated whether surgery with an LP or hemiarthroplasty (HA) is superior to nonoperative treatment with a collar-cuff and early physiotherapy in the treatment of 3- or 4-part PHF involving the surgical neck. What did the researchers do and find? We randomly allocated 160 patients to either nonoperative treatment or operative treatment with HA or LP. We recorded the Disabilities of Arm, Shoulder, and Hand (DASH) score, other measures of shoulder function and quality of life, and complications at 2-year follow-up. We found no significant or clinically important between-group differences in any of the outcomes. What do these findings mean? This trial provides no evidence that surgery is superior to nonoperative treatment in the treatment of displaced 3- or 4-part PHF involving the surgical neck in older adults. These results suggest that the current practice of performing surgery on the majority of displaced 3- or 4-part proximal fractures of the humerus in older adults may not be beneficial. The limitation is the trial was ended before intended group sizes.