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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.

SUBMITTER: D'Ambrosi R 

PROVIDER: S-EPMC8982177 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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

D'Ambrosi Riccardo R   Toni Aldo A   Czubak Jaroslaw J   Guadilla Jorge J   Lieber Lawrence L   Mariani Ilaria I   Ursino Nicola N  

SICOT-J 20220404


<h4>Introduction</h4>This multicenter prospective cohort study aimed to assess the safety and clinical and radiologic performance of the CLS<sup>®</sup> Brevius<sup>TM</sup> Stem with Kinectiv<sup>®</sup> Technology.<h4>Material and methods</h4>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<sup>®</sup> Brevius<sup>TM</sup> Stem with Kinectiv<sup>®</sup> Te  ...[more]

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