Discussion
fracture, fractures
RECRUITMENT, COMPLICATION, FRAGILITY, SECONDARY, COMPLICATIONS
This multicenter, assessor-blinded, randomized trial involving adult patients aged 60 years and older with 3- and 4-part PHF revealed that operative treatment with LP or HA was not superior to nonoperative treatment with regard to the primary outcome, DASH, assessed at 24-month follow-up. Moreover, the nonoperative group had significantly fewer complications and AEs leading to reoperations. Although all groups showed significant improvement in primary outcome until 12 months, there was no further improvement at 24 months, which is in contrast to the findings of previous smaller trials [In this study, we found no between-group differences based on the confidence intervals in any of the used outcome measures, including our primary outcome DASH and secondary outcomes CS, OSS, EQ-5D, 15D, VAS, or mortality.After completing our previous and present PHF studies, combined with the recent Cochrane review, we can acknowledge that the operative treatment of PHF does not provide added benefits in outcomes compared to nonoperative treatment [We detected a high rate of complications of up to 45% in the LP group. However, our complication rates were mainly higher than those reported in the current literature, where rates of up to 29% have been reported [In all 3 treatment methods, the shoulder function, measured with DASH, CS, or OSS, remained clinically worse at 1 and 2 years after the fracture when compared to the prefracture baseline level. Recovery after multipart fracture seems to differ from that of 2-part fractures. Indeed, the results of our previous study showed that patients with 2-part fractures regained the prefracture level of function at 1 year [Interestingly, the best DASH scores but at the same time the poorest CS scores (not exceeding the MCID) were observed in the HA group. The discrepancy between these 2 contradicting results might be explained by the assumption that patients slowly adapt to the poor postfracture function in their shoulder, as a portion of the raw points in CS is formed from muscle strength testing and range of motion [A recent study suggests that fracture is a sign not only of bone fragility but also of a frail patient, resembling patients with hip fractures [Some limitations in this trial warrant discussion. We ceased recruitment before the predefined power calculation. The results of the preplanned interim analysis after two-thirds of the recruitment was completed revealed no significant differences between treatment alternatives. The trial recruitment period was longer than expected due to a high number of exclusions after assessment of eligibility, since the nonoperative treatment grew more standard in the Nordic countries during the trial. A strength of the study is the multinational, multicenter nature of this NITEP group collaboration, which gives the results high external validity.It must be acknowledged that in the study, we only investigated nonoperative, HA, and LP treatment options for 3- and 4-part PHF. These were, however, the most relevant treatment options at the start of the trial. Reverse shoulder arthroplasty (RSA) has emerged as a treatment option but was not included in the present study. Furthermore, the number of RSA operations was not screened during the trial. Nevertheless, the NITEP group has already initiated a trial to investigate the outcomes of RSA in comparison to nonoperative treatment (The main conclusion of the present trial is that 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. When compared to the prefracture level, functional outcomes still remain at a lower level 1 and 2 years after the fracture. In addition, we observed a high rate of complications related to operative treatments. Further studies should focus on nonoperative methods of treatment, for example, the rehabilitation of these frail patients.