How Does Implant Survivorship Vary with Different Corail Femoral Stem Variants? Results of 51,212 Cases with Up to 30 Years Of Follow-up from the Norwegian Arthroplasty Register

Abstract Background The Corail® cementless stem (DePuy Synthes) has been used in Norway since 1987 and is one of the most frequently used stems in THA worldwide. Although the published survival results of the standard Corail stem have been good, little is known about the long-term (more than 20 years) survival of other stem design variants. Further, some changes were made to the extramedullary part of the stem in 2003, and the effect of these changes on survival is unknown. Questions/purposes (1) What is the survival up to 30 years of the standard collarless Corail femoral stem, and were extramedullary changes (slimmer, polished and rectangular neck, shorter taper) associated with differences in survivorship? (2) How does the 10-year survival and the risk of revision of other Corail stem variants, including the standard collared stem, coxa vara collared stem, and high offset collarless stem, compare with those of the standard collarless stem? (3) Which factors are associated with an increased risk of revision of the Corail stem, and are there any differences in those factors among the four stem variants? Methods Data for this study were drawn from the Norwegian Arthroplasty Register. Since 1987, THAs have been registered in the Norwegian Arthroplasty Register with completeness of data greater than 97% for primary THAs and 93% for revisions. To study survivorship with up to 30 years of follow-up (1987 to 2018; median 7.7-year follow-up), and to compare the original stem with stems with extramedullary modifications, we included 28,928 standard collarless Corail stems in 24,893 patients (mean age at time of implantation 62 years; 66% [16,525 of 24,893] were women). To compare the newer stem variants with the standard collarless stem (2008 to 2018), we included 20,871 standard collarless, 10,335 standard collared, 6760 coxa vara collared, and 4801 high offset collarless stems. Survival probabilities were estimated using the Kaplan-Meier method with endpoints of stem revision, revision due to aseptic stem loosening, and periprosthetic fracture. The endpoint of all noninfectious causes of THA revision (including cup revision) was additionally analyzed for the long-term comparison. The proportion of patients who died was limited, and there was no difference in death rate between the groups compared. Therefore, we believe that competing events were not likely to influence survivorship estimates to a large degree. To compare different stem variants and evaluate factors that could be associated with the risk of revision, we calculated hazard ratios using Cox regression analyses with adjustments for gender, age group, surgical approach, diagnosis, and stem size. Results The 30-year Kaplan-Meier survival of the standard collarless stem was 88.4% (95% confidence interval 85.4% to 91.4%), 93.3% (95% CI 91.1% to 95.5%), and 94.4% (95% CI 92.0% to 96.8%) using stem revision for any noninfectious cause, aseptic loosening, and periprosthetic fracture of the femur as endpoints, respectively. There was no difference in survival between the original stem and the modified stem. The 10-year Kaplan-Meier survivorship free of stem revision (all causes including infection) was 97.6% (95% CI 97.2% to 98.0%) for the standard collarless stem, 99.0% (95% CI 98.8% to 99.2%) for the standard collared stem, 97.3% (95% CI 96.3% to 98.3%) for the coxa vara collared stem, and 95.0% (95% CI 93.6% to 96.4%) for the high offset collarless stem. Compared with the standard collarless stem, the standard collared stem performed better (HR 0.4 [95% CI 0.3 to 0.6]; p < 0.001) and the high offset collarless stem performed more poorly (HR 1.4 [95% CI 1.1 to 1.7]; p = 0.006) with any stem revision as the endpoint, and similar results were found with revision for aseptic stem loosening and periprosthetic fracture as endpoints. Controlling for the noted confounders, the standard collared stem had a lower revision risk. The high offset collarless stem had an increased stem revision risk for any reason (HR 1.4 [95% CI 1.1 to 1.7]; p = 0.006) and aseptic loosening (HR 1.6 [95% CI 1.1 to 2.3]; p = 0.022). Other factors associated with an increased risk of stem revision for all stem variants were being a man (HR 1.7 [95% CI 1.4 to 2.0]; p < 0.001), age 70 to 79 years and 80 years and older compared with the age group of 50 to 59 years (HR 1.6 [95% CI 1.2 to 2.0]; p < 0.001 and HR 1.9 [95% CI 1.4 to 2.6]; p < 0.001, respectively), the anterior approaches (direct anterior Smith-Petersen and anterolateral Watson-Jones combined) compared with the posterior approach (HR 1.4 [95% CI 1.1 to 1.7]; p = 0.005), as well as a preoperative nonosteoarthritis diagnosis (HR 1.3 [95% CI 1.0 to 1.6]; p = 0.02) and small stem sizes (sizes 8-11) compared with the medium sizes (sizes 12-15) (HR 1.4 [95% CI 1.1 to 1.6]; p = 0.001). The very small sizes (8 and 9) were associated with a 2.0 times higher risk of revision (95%. CI 1.4 to 2.6; p < 0.01) compared with all other sizes combined. Conclusion When using the uncemented Corail stem, surgeons can expect good results with up to 30 years of follow-up. Our results should be generalizable to the typical surgeon at the average hospital in a comparable setting. From our results, using a collared variant would be preferable to a collarless one. Due to an increased risk of periprosthetic fracture, caution with the use of the uncemented Corail stem in patients older than 70 years, especially in women, is warranted. Poorer stem survival should also be expected with the use of small stem sizes. The risk of periprosthetic fractures for the Corail uncemented stem versus cemented stems in different age categories has not been extensively examined, nor has the use of a collar for different age groups and genders, and both should be subjects for further investigation. Level of Evidence Level III, therapeutic study.