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

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.

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.

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.

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.