一种新型无水泥股骨干设计的持续中期稳定性：放射立体分析研究

IF 1.4 3区医学 Q4 ENGINEERING, BIOMEDICAL

Clinical Biomechanics Pub Date : 2025-05-15 DOI:10.1016/j.clinbiomech.2025.106560

Stuart A. Callary , Deepti K. Sharma , Simon P. Coffey , Rami M. Sorial

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引用次数: 0

摘要

使用放射立体分析测量早期微运动是评估新种植体性能的金标准。本研究的目的是评估新型无水泥Paragon椎体在5年内的持续稳定性。次要目的是评估患者报告的结果，并将2至5年的持续稳定性与现有的金标准Corail系统进行比较。方法对放射性立体分析研究进行简短的跟踪报道。在这项为期两年的研究中，最初的46名患者中，有4名患者失去了随访，3名患者死亡，5名患者转移到州际，7名患者退出了研究。我们前瞻性地回顾了27例初次全髋关节置换术患者，他们在5年内接受了放射检查，进行了头部放射立体分析，测量了髋关节的平移和旋转移动。研究结果：竹节茎5年的沉降中值为−0.428 mm（范围为−0.107 ~−1.092），2 ~ 5年的沉降中值为−0.010 mm（范围为0.115 ~−0.269）。与Corail树干2 ~ 6年的稳定性相比，Paragon树干表现出相似的沉降（p = 0.09）；内侧平移（p = 0.0033）、前平移(p <；0.0001)， 2 - 5岁前倾（p = 0.0004）和前倾（p = 0.015）。平均牛津髋关节评分在第一年内显著提高，在2年（44.7,SD 5.9）和5年（44.0,SD 8）之间没有下降。解释：Paragon系统在长达5年的随访中显示出持续的稳定性，这对于这种新设计的进一步临床应用是令人鼓舞的。

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Continued mid-term stability of a novel cementless femoral stem design: A radiostereometric analysis study

Background

Measuring early micromotion using radiostereometric analysis is the gold standard to evaluate new implant performance. The aim of this study was to assess the continued stability of a new cementless Paragon stem at 5 years. Secondary aims were to assess patient reported outcomes and compare the continued stability between 2 and 5 year to an existing gold standard, the Corail stem.

Methods

This is a brief follow-up report of a radiostereometric analysis study. Of the original 46 patients in the 2 year study, four patients were lost to follow-up, three had died, five relocated interstate and seven withdrew from the study. We prospectively reviewed 27 primary total hip arthroplasty patients who underwent radiographic examinations at 5 years for beaded radiostereometric analysis measurements of stem translational and rotation migration.

Findings

Median subsidence of the Paragon stem at 5 years was −0.428 mm (range − 0.107 to −1.092) and the median stem subsidence between 2 and 5 years was −0.010 mm (0.115 to −0.269). When compared to the historical Corail stem stability between two and six years, the Paragon stem demonstrated similar subsidence (p = 0.09); and significantly less medial translation (p = 0.0033), anterior translation (p < 0.0001), anterior tilt (p = 0.0004) and anteversion (p = 0.015) between 2 and 5 years. The mean Oxford Hip Score improved substantially within the first year and did not decrease between 2 (44.7, SD 5.9) and 5 years (44.0, SD 8).

Interpretation

The Paragon stem showed continued stability up to 5 years follow-up which is encouraging for the further clinical use of this new design.

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来源期刊

Clinical Biomechanics 医学-工程：生物医学

CiteScore

3.30

自引率

5.60%

发文量

189

审稿时长

12.3 weeks

期刊介绍： Clinical Biomechanics is an international multidisciplinary journal of biomechanics with a focus on medical and clinical applications of new knowledge in the field. The science of biomechanics helps explain the causes of cell, tissue, organ and body system disorders, and supports clinicians in the diagnosis, prognosis and evaluation of treatment methods and technologies. Clinical Biomechanics aims to strengthen the links between laboratory and clinic by publishing cutting-edge biomechanics research which helps to explain the causes of injury and disease, and which provides evidence contributing to improved clinical management. A rigorous peer review system is employed and every attempt is made to process and publish top-quality papers promptly. Clinical Biomechanics explores all facets of body system, organ, tissue and cell biomechanics, with an emphasis on medical and clinical applications of the basic science aspects. The role of basic science is therefore recognized in a medical or clinical context. The readership of the journal closely reflects its multi-disciplinary contents, being a balance of scientists, engineers and clinicians. The contents are in the form of research papers, brief reports, review papers and correspondence, whilst special interest issues and supplements are published from time to time. Disciplines covered include biomechanics and mechanobiology at all scales, bioengineering and use of tissue engineering and biomaterials for clinical applications, biophysics, as well as biomechanical aspects of medical robotics, ergonomics, physical and occupational therapeutics and rehabilitation.