Volume 8, 2022
|Number of page(s)||18|
|Published online||04 April 2022|
Satisfactory clinical and radiologic outcomes with a new shorter and modular stem for end-stage hip osteoarthritis: an international prospective multicentre pilot study
IRCCS Istituto Ortopedico Galeazzi, 20161 Milano, Italy
2 IRCCS Istituto Ortopedico Rizzoli, 40136 Bologna, Italy
3 SPSK im.Prof.A.Grucy, 05-400 Otwock, Poland
4 HUA Santiago, 01004 Vitoria, Spain
5 DuPage Medical Group Ltd., Downers, Grove, IL 60540, USA
6 Institute for Maternal and Child Health – IRCCS “Burlo Garofolo”, 34137 Trieste, Italy
* Corresponding author: firstname.lastname@example.org
Accepted: 14 February 2022
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.
Key words: Hip Arthroplasty / Multicenter Study / Short Stem / Brevius CLS / Blood Ion Levels
© The Authors, published by EDP Sciences, 2022
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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