Reverse Shoulder Arthroplasty Is Superior to Plate Fixation at 2 Years for Displaced Proximal Humeral Fractures in the Elderly: A Multicenter Randomized Controlled Trial

Abstract

Background: Almost one-third of patients with proximal humeral fractures are treated surgically, and the number is increasing. When surgical treatment is chosen, there is sparse evidence on the optimum method. The DelPhi (Delta prosthesis-PHILOS plate) trial is a clinical trial comparing 2 surgical treatments. Our hypothesis was that reverse total shoulder arthroplasty (TSA) yields better clinical results compared with open reduction and internal fixation (ORIF) using an angular stable plate.

Methods: The DelPhi trial is a randomized controlled trial comparing reverse TSA with ORIF for displaced proximal humeral fractures (OTA/AO types 11-B2 and 11-C2) in elderly patients (65 to 85 years of age). The primary outcome measure was the Constant score at a 2-year follow-up. The secondary outcome measures included the Oxford Shoulder Score and radiographic evaluation. Results were reported as the mean difference with 95% confidence interval (CI). The intention-to-treat principle was applied for crossover patients.

Results: There were 124 patients included in the study. At 2 years, the mean Constant score was 68.0 points (95% CI, 63.7 to 72.4 points) for the reverse TSA group compared with 54.6 points (95% CI, 48.5 to 60.7 points) for the ORIF group, resulting in a significant mean difference of 13.4 points (95% CI, 6.2 to 20.6 points; p < 0.001) in favor of reverse TSA. When stratified for fracture classification, the mean score was 69.3 points (95% CI, 63.9 to 74.7 points) for the reverse TSA group and 50.6 points (95% CI, 41.9 to 59.2 points) for the ORIF group for type-C2 fractures, which yielded a significant mean difference of 18.7 points (95% CI, 9.3 to 28.2 points; p < 0.001). In the type-B2 fracture group, the mean score was 66.2 points (95% CI, 58.6 to 73.8 points) for the reverse TSA group and 58.5 points (95% CI, 49.6 to 67.4 points) for the ORIF group, resulting in a nonsignificant mean difference of 7.6 points (95% CI, -3.8 to 19.1 points; p = 0.19).

Conclusions: At a 2-year follow-up, the data suggested an advantage of reverse TSA over ORIF in the treatment of displaced OTA/AO type-B2 and C2 proximal humeral fractures in elderly patients.

Level of evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Fig. 1

The flowchart of patients in the DelPhi study. There were 270 patients with OTA/AO type-B2 or C2 fractures in the age group of 65 to 85 years assessed for eligibility. In this study, 146 patients were excluded and 124 patients were included and were allocated to either reverse TSA or ORIF. Missing data due to patients withdrawing from the study or death are shown as the cumulative value at each time point. Some patients were not available for follow-up at certain time points but were included in the analysis if they were available for testing at other time points.

Fig. 2

The overall mean Constant score for the reverse TSA (RTSA) group and the ORIF group. The error bars indicate the 95% CIs. The Constant score ranges from 0 (worst) to 100 points (best) and consists of 4 dimensions of shoulder function: pain, activities of daily living, range of motion, and strength.

Fig. 3

The mean Constant score for the reverse TSA (RTSA) group and the ORIF group stratified by the OTA/AO fracture classification. The error bars indicate the 95% CIs.

Fig. 4

The mean Constant score for the reverse TSA (RTSA) group and the ORIF group stratified by age groups. The error bars indicate the 95% CIs.

Fig. 5

The overall mean Oxford Shoulder Score for the reverse TSA (RTSA) group and the ORIF group. The error bars indicate the 95% CIs. The Oxford Shoulder Score consists of 12 questions concerning shoulder pain, shoulder function, and activities of daily living and ranges from 0 points (worst) to 48 points (best).

Fig. 6

The mean Oxford Shoulder Score for the reverse TSA (RTSA) group and the ORIF group stratified by the OTA/AO fracture classification. The error bars indicate the 95% CIs.

Fig. 7

The mean Oxford Shoulder Score for the reverse TSA (RTSA) group and the ORIF group stratified by age groups. The error bars indicate the 95% CIs.