What is the Long-term Wear of a 5-Mrad Highly Crosslinked Polyethylene Liner? A 14-year RSA Study.

IF 4.2 2区 医学 Q1 ORTHOPEDICS
Stuart A Callary, Deepti K Sharma, Taisha M D'Apollonio, Owain Critchley, Graham Mercer, Christopher Wilson, David G Campbell
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引用次数: 0

Abstract

Background: Lower doses of irradiation (≤ 5 Mrad) during the manufacture of highly crosslinked polyethylene acetabular liners may result in less crosslinking and an increased wear rate. Radiostereometric analysis (RSA) studies have found that wear of more highly irradiated highly crosslinked polyethylene liners (7 to 10 Mrad) decreases at longer-term follow-up compared with earlier reports of the same cohorts. Although wear of 5-Mrad irradiated liners appears to increase at midterm follow-up, it is unclear whether that remains true at longer follow-up.

Questions/purposes: We asked: (1) In patients who underwent THA with a 5-Mrad highly crosslinked polyethylene liner, what is the wear rate evaluated with RSA during the first 14 years? (2) Does the wear rate decrease after 6 years in situ?

Methods: This is a brief follow-up of prior RSA studies performed at 2 and 6 years. We prospectively reviewed the longer-term wear rate in 13 patients who underwent primary THAs with the same design of a 5-MRad irradiated crosslinked acetabular liner and a 28-mm cobalt-chromium articulation. Of the initial 30 patients who were enrolled, 13 (43%) were available at the 14-year timepoint; nine patients had died, 1 patient had withdrawn, 1 had an intraoperative fracture, 3 patients were too infirm to have radiographs, 2 had no baseline RSA radiographs, and 1 had poor-quality RSA images. Tantalum markers were inserted during surgery, and all patients had RSA radiographic examinations at 1 week, 6 months, and 1, 2, 6, and 14 years postoperatively.

Results: The mean ± standard deviation proximal, 2D, and 3D wear rates calculated between 1 year and 14 years were 0.019 ± 0.013 mm, 0.022 ± 0.015 mm, and 0.025 ± 0.019 mm per year, respectively. No patient had proximal 2D or 3D wear rates exceeding 0.06 mm per year. An increasing wear rate over time was measured for proximal and 2D wear rates between 6 and 14 years (0.024 and 0.030 mm per year) compared with that between 1 and 6 years (0.008 and 0.010 mm per year; p = 0.03).

Conclusion: The proximal, 2D, and 3D wear of a highly crosslinked polyethylene liner produced using 5-Mrad radiation remains low in the longer-term. With the small numbers available in a long-term RSA study such as this, we confirmed that the wear rate did not decrease at longer-term follow-up, unlike previous RSA studies of more highly irradiated highly crosslinked polyethylene liners. Nevertheless, the wear rate remains very low and below the threshold typically associated with the development of osteolysis (0.1 mm/year of wear). This should provide assurance to orthopaedic surgeons monitoring patients with this 5-Mrad irradiated liner in situ, while providing useful information to manufacturers of future highly crosslinked polyethylene liners.

Level of evidence: Level IV therapeutic study.

5 射线高度交联聚乙烯衬垫的长期磨损情况如何?一项为期 14 年的 RSA 研究。
背景:在制造高交联聚乙烯髋臼衬垫时,较低剂量的辐照(≤ 5 Mrad)可能会导致交联程度降低和磨损率增加。放射性立体计量分析(RSA)研究发现,与早期相同队列的报告相比,经过较高辐照的高交联聚乙烯内衬(7 到 10 Mrad)在长期随访中的磨损率有所下降。虽然 5-Mrad 辐照内衬的磨损在中期随访时似乎有所增加,但在长期随访时是否仍然如此尚不清楚:我们的问题是:(1) 在使用 5-Mrad 高交联聚乙烯衬垫接受 THA 手术的患者中,在最初的 14 年中使用 RSA 评估的磨损率是多少?(2) 在原位使用 6 年后,磨损率是否会降低?这是对之前进行的 2 年和 6 年 RSA 研究的简要跟踪。我们前瞻性地回顾了13例接受初级THA的患者的长期磨损率,这些患者采用了相同的设计,即5-MRad辐照交联髋臼衬垫和28毫米钴铬关节。在最初入组的 30 名患者中,有 13 名(43%)患者在 14 年的时间节点上进行了手术;其中 9 名患者死亡,1 名患者退出手术,1 名患者术中骨折,3 名患者体弱多病,无法拍摄射线照片,2 名患者没有基线 RSA 影像,1 名患者的 RSA 图像质量较差。术中插入钽标记,所有患者在术后1周、6个月以及1年、2年、6年和14年进行了RSA影像学检查:1 年至 14 年间计算出的近端、二维和三维磨损率的平均值(± 标准差)分别为每年 0.019 ± 0.013 毫米、0.022 ± 0.015 毫米和 0.025 ± 0.019 毫米。没有患者的近端 2D 或 3D 磨损率超过每年 0.06 毫米。与1至6年的磨损率(每年0.008和0.010毫米;P = 0.03)相比,6至14年的近端和2D磨损率(每年0.024和0.030毫米)随着时间的推移而增加:结论:使用5-Mrad辐射生产的高交联聚乙烯衬垫的近端、二维和三维磨损在较长时间内仍然较低。由于像这样的长期 RSA 研究可用的人数较少,我们证实在长期随访中磨损率并没有降低,这与之前对辐照度更高的高交联聚乙烯衬垫进行的 RSA 研究不同。不过,磨损率仍然很低,低于通常与骨溶解发展相关的阈值(0.1 毫米/年磨损)。这应该能为使用这种5-Mrad辐照衬垫对患者进行原位监测的骨科医生提供保证,同时也能为未来高交联聚乙烯衬垫的制造商提供有用的信息:IV级治疗研究。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
7.00
自引率
11.90%
发文量
722
审稿时长
2.5 months
期刊介绍: Clinical Orthopaedics and Related Research® is a leading peer-reviewed journal devoted to the dissemination of new and important orthopaedic knowledge. CORR® brings readers the latest clinical and basic research, along with columns, commentaries, and interviews with authors.
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