Effectiveness of Stress Shielding Prevention Using a Low Young's Modulus Ti-33.6Nb-4Sn Stem: A 7-Year Follow-Up Study.

Abstract

Background: Stress shielding (SS) after total hip arthroplasty (THA) leads to proximal femoral bone loss and increases the risk of complications such as implant loosening and periprosthetic fracture. While various low-stiffness stems have been developed to prevent SS, they often compromise mechanical stability. A novel femoral stem composed of Ti-33.6Nb-4Sn (TNS) alloy offers a gradually decreasing Young's modulus from proximal to distal regions, potentially improving load distribution and reducing SS. This study aimed to evaluate the mid-term clinical and radiographic outcomes of the TNS stem, with a particular focus on its effectiveness in suppressing SS.

Methods: A prospective clinical study was conducted involving 35 patients who underwent THA using the TNS stem, with a minimum follow-up of 7 years. Twenty-one patients with Ti6Al4V metaphyseal-filling stems served as controls. Clinical outcomes were assessed using Japanese Orthopaedic Association (JOA) scores, and radiographic SS was graded using Engh's classification and analyzed in Gruen zones. Inter-examiner reliability and statistical comparisons between groups were performed using appropriate tests.

Results: The TNS group showed significantly higher preoperative JOA scores than the control group, but no significant difference in final scores. Both groups demonstrated significant improvement postoperatively. Third-degree SS occurred in the TNS group, although the overall SS grade distribution was significantly lower than in the control group (p = 0.03). SS frequency was significantly reduced in Gruen Zones 2, 3, and 6 in the TNS group.

Conclusions: The TNS stem demonstrated a significant reduction in SS progression compared to conventional titanium stems over a 7-year period, with comparable clinical outcomes. However, the occurrence of third-degree SS indicates that material optimization alone may be insufficient, highlighting the need for further design improvements.