Early radiographic evaluation of an anatomic porous tantalum tibia: A prospective, multi-center, non-randomized clinical study

Abstract

Background

Excellent survival rates have been reported for total knee arthroplasty (TKA) performed with cementless porous metal tibial components. More data, however, is necessary to assess the survival and radiographic results of modular implants with anatomic designs. The purpose of this study was to investigate the early radiographic, survival, and clinical outcomes of a cementless tantalum metal tibial implant with a modular anatomic component.

Methods

An early follow-up of a prospective, multi-center, non-randomized outcomes study of patients who received cementless tibial implants in primary TKA between 2018 and 2020 was performed. A total of 148 implants were available for review. Radiographs, the Forgotten Joint Score (FJS-12), Oxford Knee Score (OKS), patient satisfaction, and adverse events were collected for at least two-years post-operative. A minimum of two-years follow-up was available for 119 patients and evaluated for progressive radiolucent lines (RLLs).

Results

The mean follow-up was 2.2 ± 0.6 years, and the two-year implant survival rate was 98.59% (95% C.I.: 94.46, 99.64) with no aseptic revisions during the follow-up period. Progressive tibial RLLs were present in 3.4% of patients at two-years follow-up, but were all less than 2 mm with all combined RLLs less than 4 mm. The FJS-12 and OKS all significantly (p < 0.0001) increased and exceeded their respective minimal clinical important differences, and 93% of patients were satisfied at two-years follow-up.

Conclusion

This study supports excellent survivorship, clinical and patient reported outcomes using cementless, fixed bearing TKA with minimal complications at early follow-up. Further follow-up is necessary to confirm the sustainability of the clinical outcomes and to evaluate mid- to long-term survivorship.