A cost-effectiveness analysis of reverse total shoulder arthroplasty compared with locking plates in the management of displaced proximal humerus fractures in the elderly: the DelPhi trial.

AIM: To evaluate the cost-effectiveness of surgical treatment with reverse total shoulder arthroplasty (RTSA) compared with open reduction and internal fixation (ORIF) with a locking plate for patients 65-85 years old with a displaced proximal humerus fracture. METHODS: A cost-utility analysis was conducted alongside a multicenter randomized controlled trial, taking a health care perspective. A total of 124 patients with displaced proximal humerus fractures were randomized to treatment with RTSA (n = 64) or ORIF (n = 60) during a 2-year period. The outcome measure was quality-adjusted life years derived from the generic questionnaire 15D in an intention to treat population. The results were expressed as incremental cost-effectiveness ratios, and a probabilistic sensitivity analysis was performed to account for uncertainty in the analysis. RESULTS: At 2 years, 104 patients were eligible for analyses. The mean quality-adjusted life year was 1.24 (95% confidence interval: 1.21-1.28) in the RTSA group and 1.26 (95% confidence interval: 1.22-1.30) in the ORIF group. The mean cost in the RTSA group (€36.755 [€17,654-€55,855]) was higher than that in the ORIF group (€31.953 [€16,226-€47,279]). Using incremental cost-effectiveness ratio, ORIF was the dominant treatment. When using a probabilistic sensitivity analysis with 1000 replications, the plots were centered around origo. This indicates that there is no significant difference in cost or effect. CONCLUSION: In the cost-utility analysis of treatment of displaced proximal humeral fractures, there were no differences between RTSA and ORIF.

Comparison of 2 Postoperative Therapy Regimens After Trapeziectomy Due to Osteoarthritis: A Randomized, Controlled Trial.

PURPOSE: The main aim of the present study was to evaluate whether early mobilization after trapeziectomy in the first carpometacarpal joint is noninferior to a postoperative regimen comprising the use of a rigid orthosis and mobilization after 6 weeks, with regards to patient-reported activity performance and the effect of surgery in patients with first carpometacarpal osteoarthritis. METHODS: In this prospective, randomized, controlled noninferiority trial, participants were assessed at baseline (before group allocation) and at 3, 6, and 12 months after surgery. The primary outcomes were activity performance, measured using the Canadian Occupational Performance Measure (1-10, where 1 = unable to perform), and the patient-reported effect of surgery on a 6-point scale ranging from "much worse" to "completely recovered." A change of 2.0 points in the Canadian Occupational Performance Measure was used as a noninferiority margin. Secondary outcomes included hand function (patient-reported in the Measure of Activity Performance of the Hand questionnaire), pain on a numeric rating scale, grip and pinch strengths, and joint mobility. We performed both intention-to-treat and per-protocol analyses. RESULTS: Of the 59 participants (88% women) with a mean age of 65 years, 55 (93%) completed all assessments. We found no differences between the groups in primary or secondary outcomes at any time point, except for more decreased pain at rest in the intervention group (n = 28) compared with the control group (n = 27) after 12 months. The per-protocol analyses did not change these results. Fifteen participants experienced 1 or more adverse events during the first 3 months, but the types and frequencies of adverse events were similar between the 2 groups. CONCLUSIONS: A postoperative regimen with early mobilization after trapeziectomy is as safe and effective as a postoperative regimen with longer immobilization in patients with first carpometacarpal osteoarthritis. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic II.

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

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.