OBJECTIVES

The Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR) registry represents community sites across 28 states. The US TJR outcome data are often limited to the CMS data that captures only older adults (>65 years) and has important limitations such as inaccurate coding. The purpose of this registry analysis is to assess 12-month patient and implant-outcomes associated with the Corail Pinnacle (C/P) implant combination used in primary total hip replacement (THR) in US patients of all ages, compared to all other cementless hips in the database (All FORCE).

METHODS

Primary THR patients with complete pre-op and 12-month data were retrospectively identified. The C/P group includes n=230 patients and All FORCE n=3,907. C/P cases were performed by 14 surgeons at 8 sites in 5 states. No differences were identified between the groups in patient age, gender, BMI or ethnicity (all p>0.05). No differences were identified in pre-operative co-morbidities (p=0.11) or in incidence of lower back pain (p=0.53). General physical health (SF36-PCS) and hip-specific (HOOS) patient reported outcome measures (PROMs) were captured at pre-operative (100%) and 12-months (89% of patients). Revision procedures were identified by matching CMS data for patients >65 years and by self-report at time of PROMs with chart review validation for those <65 years.

RESULTS

In C/P, PCS improved from pre-op =30.1 (SD 9.08) to 45.48 (SD 10.97) at 12 months, the HOOS pain score improved from 41.60 (SD 19.10) to 89.71 (SD 13.28), and the HOOS ADL score improved from 43.59 (SD 19.94) to 87.07 (SD 14.55). The pre-op to 12-month changes all exceeded the minimal clinically important difference (MCID) and were similar to All FORCE group. The 12-month C/P crude implant revision rate was 0.9% (<1%).

CONCLUSIONS

Real world data demonstrates that the Corail Pinnacle system delivers reliable clinical outcomes and low risk of early revision.