MRI Research Laboratory, Hospital for Special Surgery, New York, NY, USA.
Biostatistics Core, Hospital for Special Surgery, New York, NY, USA.
Clin Orthop Relat Res. 2021 Dec 1;479(12):2633-2650. doi: 10.1097/CORR.0000000000001882.
The evaluation of the natural history prevalence of adverse local tissue reactions (ALTRs) using MRI has focused only on metal-on-metal (MoM) bearing surfaces without comparison to nonMoM bearing surfaces.
QUESTIONS/PURPOSES: To determine (1) the longitudinal changes and differences in blood metal ion levels in patients with hip resurfacing arthroplasty (HRA), ceramic-on-ceramic (CoC) THA, and metal-on-polyethylene (MoP) THA compared with those undergoing ceramic-on-polyethylene (CoP) THA; (2) how the longitudinal change of synovial reaction classification in patients with HRA, CoC THA, and MoP THA compares with those undergoing CoP THA, and whether there is an association between the presence of an ALTR or metallosis on MRI with corresponding patient-reported outcomes, or the presence of capsular dehiscence; and (3) differences in blood metal ion levels between patients undergoing HRA with an ALTR or metallosis on MRI and those with HRA without these conditions.
Between March 2014 and February 2019, 22,723 patients underwent primary HRA and THA at one center. Patients received an HRA based on their desired athletic level after surgery and the presence of normal acetabular and proximal femoral bone morphology without osteopenia or osteoporosis. Two percent (342 of 22,723) of patients were contacted to participate, and 71% (243 of 342 hips in 206 patients) were enrolled for analysis at baseline. The patients underwent arthroplasty for degenerative joint disease, and 25 patients withdrew over the course of the study. We included patients who were more than 1 year postarthroplasty. All participants had an MRI examination and blood serum ion testing and completed a Hip Disability and Osteoarthritis Outcome Score survey annually for four years (baseline, year 1, year 2, year 3). Morphologic and susceptibility-reduced MR images were evaluated by a single radiologist not involved in the care of patients for the presence and classification of synovitis (Gwet AC1: 0.65 to 0.97), synovial thickness, and volume (coefficient of repeatability: 1.8 cm3). Linear mixed-effects models were used to compare the mean synovial thickness, synovial volume, and Hip Disability and Osteoarthritis Outcome Score subscales between bearing surfaces at each timepoint and within each bearing surface over time. Marginal Cox proportional hazards models were used to compare the time to and the risk of developing ALTR only, metallosis only, and ALTR or metallosis between bearing surfaces. All models were adjusted for age, sex, BMI, and length of implantation based on known confounders for hip arthroplasty. Adjustment for multiple comparisons was performed using the Dunnett-Hsu method.
Patients with unilateral HRA had higher cobalt and chromium serum ion levels (baseline: 1.8 ± 0.8 ppb, year 1: 2.0 ± 1.5 ppb, year 2: 2.1 ± 1.2 ppb, year 3: 1.6 ± 0.7 ppb) than those with unilateral CoP bearings (baseline: 0.0 ± 0.1 ppb, year 1: 0.1 ± 0.3 ppb, year 2: 0.0 ± 0.2 ppb, year 3: 0.0 ± 0.0 ppb) at all timepoints (p < 0.001 for each time point). More patients who received an HRA developed ALTR or metallosis on MRI than did patients with CoP bearings (hazard ratio 4.8 [95% confidence interval 1.2 to 18.4]; p = 0.02). There was no association between the longitudinal change of synovial reaction to ALTR or metallosis on MRI with patient-reported outcomes. In addition, there was no association between the presence of dehiscence at baseline and the subsequent development of ALTR or metallosis, as seen on MRI. There were elevated cobalt (4.7 ± 3.5 ppb) and chromium (4.7 ± 2.6 ppb) serum levels in patients with unilateral HRA who had an ALTR or metallosis present on MRI at year 1 compared with patients without an ALTR or metallosis on MRI (cobalt: 1.8 ± 1.0 ppb, mean difference 4.7 ppb [95% CI 3.3 to 6.0]; p < 0.001; chromium: 2.3 ± 0.5 ppb, mean difference 3.6 ppb [95% CI 2.2 to 5.0]; p < 0.001) as well as for chromium at year 3 (3.9 ± 2.4 ppb versus 2.2 ± 1.1 ppb, mean difference 1.3 ppb [95% CI 0.3 to 2.4]; p = 0.01).
We found a higher proportion of ALTR or metallosis on MRI in patients with HRA compared with patients with CoP, even when patient self-assessed symptomatology of those with an ALTR or metallosis on MRI was not different than the absence of these features. MRI detected ALTRs in high-function patients, emphasizing that an annual clinical assessment dependent on survey or blood ion testing alone may not detect soft tissue complications. The results of this study are in line with prior consensus recommendations of using MRI as part of a routine follow-up protocol for this patient population.
Level III, therapeutic study.
使用 MRI 评估不良局部组织反应 (ALTR) 的自然病史流行率仅集中在金属对金属 (MoM) 轴承表面，而没有与非 MoM 轴承表面进行比较。
问题/目的：确定 (1) 髋关节表面置换术 (HRA)、陶瓷对陶瓷 (CoC) 全髋关节置换术和金属对聚乙烯 (MoP) 全髋关节置换术患者的血液金属离子水平的纵向变化和差异，与接受陶瓷对聚乙烯 (CoP) 全髋关节置换术的患者相比；(2) HRA、CoC 全髋关节置换术和 MoP 全髋关节置换术患者的滑膜反应分类的纵向变化与接受 CoP 全髋关节置换术的患者相比如何，以及 MRI 上是否存在 ALTR 或金属沉着与相应的患者报告结果之间是否存在关联，或者与 MRI 上存在的囊袋破裂之间是否存在关联；(3) MRI 上存在 ALTR 或金属沉着的 HRA 患者与无这些情况的 HRA 患者之间的血液金属离子水平差异。
2014 年 3 月至 2019 年 2 月，一家中心对 22723 例患者进行了初次 HRA 和全髋关节置换术。患者根据术后期望的运动水平以及髋臼和股骨近端骨形态正常，无骨质疏松或骨质疏松症接受 HRA。联系了 2%（342 例）的患者参与，206 例中有 71%（243 髋）在基线时入组分析。患者接受全髋关节置换术治疗退行性关节病，在研究过程中有 25 例患者退出。我们纳入了术后超过 1 年的患者。所有参与者均接受了 MRI 检查和血清离子检测，并在 4 年内每年完成一次髋关节残疾和骨关节炎结果评分调查（基线、第 1 年、第 2 年、第 3 年）。一名未参与患者治疗的放射科医生对形态学和磁敏感降低的 MR 图像进行了滑膜炎（Gwet AC1：0.65 至 0.97）、滑膜厚度和体积的存在和分类的评估（重复性系数：1.8cm3）。线性混合效应模型用于比较各时间点不同轴承表面之间和同一轴承表面随时间推移的平均滑膜厚度、滑膜体积和髋关节残疾和骨关节炎结果评分子量表。边际 Cox 比例风险模型用于比较仅存在 ALTR、仅存在金属沉着以及 ALTR 或金属沉着的轴承表面之间的时间和发展风险。所有模型均根据髋关节置换术的已知混杂因素，根据年龄、性别、BMI 和植入物长度进行了调整。使用 Dunnett-Hsu 方法进行多重比较调整。
单侧 HRA 患者的钴和铬血清离子水平（基线：1.8±0.8ppb，第 1 年：2.0±1.5ppb，第 2 年：2.1±1.2ppb，第 3 年：1.6±0.7ppb）高于单侧 CoP 轴承患者（基线：0.0±0.1ppb，第 1 年：0.1±0.3ppb，第 2 年：0.0±0.2ppb，第 3 年：0.0±0.0ppb）（各时间点 p<0.001）。接受 HRA 的患者中，MRI 上出现 ALTR 或金属沉着的患者多于 CoP 轴承患者（风险比 4.8[95%置信区间 1.2 至 18.4]；p=0.02）。MRI 上 ALTR 或金属沉着的滑膜反应纵向变化与患者报告的结果之间没有关联。此外，基线时囊袋破裂的存在与随后 MRI 上出现的 ALTR 或金属沉着之间没有关联。与 MRI 上无 ALTR 或金属沉着的患者相比，单侧 HRA 患者在第 1 年时 MRI 上存在 ALTR 或金属沉着时，钴（4.7±3.5ppb）和铬（4.7±2.6ppb）血清水平升高（钴：1.8±1.0ppb，平均差异 4.7ppb[95%置信区间 3.3 至 6.0]；p<0.001；铬：2.3±0.5ppb，平均差异 3.6ppb[95%置信区间 2.2 至 5.0]；p<0.001），第 3 年时铬（3.9±2.4ppb 与 2.2±1.1ppb，平均差异 1.3ppb[95%置信区间 0.3 至 2.4]；p=0.01）。
与接受 CoP 的患者相比，我们发现 HRA 患者的 MRI 上出现 ALTR 或金属沉着的比例更高，即使 MRI 上出现 ALTR 或金属沉着的患者的症状自评与无这些特征的患者并无不同。MRI 检测到高功能患者的 ALTR，强调仅依赖于调查或血液离子检测的年度临床评估可能无法发现软组织并发症。本研究结果与先前的共识建议一致，即使用 MRI 作为该患者人群常规随访方案的一部分。
III 级，治疗性研究。
