Satisfactory clinical and radiologic outcomes with a new shorter and modular stem for end-stage hip osteoarthritis: an international prospective multicentre pilot study

Abstract

Introduction: This multicenter prospective cohort study aimed to assess the safety and clinical and radiologic performance of the CLS® BreviusTM Stem with Kinectiv® Technology. Material and Methods: A total of 222 consecutive subjects, recruited in five different centers, qualifying for primary total hip arthroplasty (THA), were enrolled in the study. All the subjects received the CLS® BreviusTM Stem with Kinectiv® Technology. All the enrolled study subjects underwent pre-operative clinical and radiographic evaluation. Additionally, all subjects underwent post-operative clinical, functional and radiographic evaluations at 6 months and 1, 2, 3, and 5 years. These evaluations included implant survival, pain and functional performance (Harris Hip Score [HHS], University of California, Los Angeles [UCLA] Activity Score, Oxford Hip Score), subject quality-of-life (EQ-5D), radiographic parameters, complications, and concentration of metal ions (aluminum and titanium) in blood. Results: No revisions were performed during the follow-up period. Of the 222 patients, only 76 completed the 5-year follow-up. Only 7 and 5 patients had aluminum and titanium 5-year evaluations, respectively. All the clinical parameters showed an overall improvement in the overtime measured with ANOVA for repeated measures; furthermore, the clinical scores showed a statistically significant improvement at 5 years with respect to pre-operative value (p < 0.001). Aluminum and titanium showed no variation for repeated measures at different time points (p > 0.05). A total of six complications were reported, of which only two were hip-related. Conclusions: The function of the CLS® BreviusTM Stem with Kinectiv® Technology indicated that subject well-being significantly increased following THA regardless of age, gender, BMI, previous surgery, primary diagnosis, and lifestyle.