Dual-Mobility Progressive Press-Fit Hemispherical Acetabular Cup in Primary Hip Arthroplasty: Safety and Efficacy. The SYMCOR-1 study [NCT04209374

Abstract

Purpose: To Estimate the short-term clinical safety and efficacy of hemispherical with flattened pole chromium-cobalt metal back dual-mobility acetabular cup with porous outer coating (HFPC-DM-HA), in primary THA. Methods: Single-center retrospective observational cohort study of consecutive patients undergoing THA with a HFPC-DMHA cup 2 years prior to study start. Prospective 2-year follow-up with letter and phone questionnaires. Results: Sampling frame: 361 patients including 59 patients (16.3%) in the cohort. 6 patients (10%) lost to follow-up. Median age 77.5 years (67, 92), 32% female, median BMI 25.2 kg.m-2 (18.4 to 56.8). Primary osteoarthritis in 80%. Median follow-up 3.0 years (2.7 to 4.1) Primary Endpoint: 2-year implant survival rate: 97% [87, 99]. Prosthetic dislocation: 0%. Secondary Endpoint: Modified HHS (pain & functional sub score) improved from baseline 39.7 [34.6, 44.7] to 75.8 [72.1, 79.6] at 1-year and to 86.7 [83.7, 89.7] at 2-year (p<0.0001). Conclusions: The short-term benefit-risk balance was deemed satisfactory