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.
Clinical Investigation for Displaced Proximal Humeral Fractures in the Elderly: A Randomized Study of Two Surgical Treatments: Reverse Total Prosthetic Replacement Versus Angular Stable Plate Philos (The DELPHI-trial)T Fjalestad et al. BMC Musculoskelet Disord 15, 323. PMID 25261913. - Randomized Controlled TrialClinicalTrials.gov Identifier: NCT01737060.
Reverse Total Shoulder Versus Angular Stable Plate Treatment for Proximal Humeral Fractures in Over 65 Years Old PatientsA Giardella et al. Muscles Ligaments Tendons J 7 (2), 271-278. PMID 29264338.Our study shows good clinical outcomes and fewer complications in both treatment options. Better clinical and daily living results are reported in RSA compared with ORIF, …
Interventions for Treating Proximal Humeral Fractures in AdultsHH Handoll et al. Cochrane Database Syst Rev (11), CD000434. PMID 26560014. - ReviewThere is high or moderate quality evidence that, compared with non-surgical treatment, surgery does not result in a better outcome at one and two years after injury for p …
A Multicenter, Prospective, Randomized, Controlled Trial of Open Reduction--Internal Fixation Versus Total Elbow Arthroplasty for Displaced Intra-Articular Distal Humeral Fractures in Elderly PatientsMD McKee et al. J Shoulder Elbow Surg 18 (1), 3-12. PMID 18823799. - Randomized Controlled TrialWe conducted a prospective, randomized, controlled trial to compare functional outcomes, complications, and reoperation rates in elderly patients with displaced intra-art …
Surgical Interventions for Treating Distal Humeral Fractures in AdultsY Wang et al. Cochrane Database Syst Rev (1), CD009890. PMID 23440844. - ReviewOverall, this review found there is either no or insufficient evidence from randomised or quasi-randomised controlled trials to determine whether surgery is, and which su …