Rush University Medical Center, Chicago Illinois, USA.
Washington University Orthopedics, Barnes Jewish Hospital, St. Louis, Missouri, USA.
Bone Joint J. 2019 Apr;101-B(4):365-371. doi: 10.1302/0301-620X.101B4.BJJ-2018-0834.R1.
Modular dual mobility (DM) prostheses in which a cobalt-chromium liner is inserted into a titanium acetabular shell ( vs a monoblock acetabular component) have the advantage of allowing supplementary screw fixation, but the potential for corrosion between the liner and acetabulum has raised concerns. While DM prostheses have shown improved stability in patients deemed 'high-risk' for dislocation undergoing total hip arthroplasty (THA), their performance in young, active patients has not been reported. This study's purpose was to assess clinical outcomes, metal ion levels, and periprosthetic femoral bone mineral density (BMD) in young, active patients receiving a modular DM acetabulum and recently introduced titanium, proximally coated, tapered femoral stem design.
This was a prospective study of patients between 18 and 65 years of age, with a body mass index (BMI) < 35 kg/m and University of California at Los Angeles (UCLA) activity score > 6, who received a modular cobalt-chromium acetabular liner, highly crosslinked polyethylene mobile bearing, and cementless titanium femoral stem for their primary THA. Patients with a history of renal disease and metal hardware elsewhere in the body were excluded. A total of 43 patients (30 male, 13 female; mean age 52.6 years (sd 6.5)) were enrolled. All patients had a minimum of two years' clinical follow-up. Patient-reported outcome measures, whole blood metal ion levels (ug/l), and periprosthetic femoral BMD were measured at baseline, as well as at one and two years postoperatively. Power analysis indicated 40 patients necessary to demonstrate a five-fold increase in cobalt levels from baseline (alpha = 0.05, beta = 0.80). A mixed model with repeated measures was used for statistical analysis.
Mean Harris Hip Scores improved from 54.1 (sd 20.5) to 91.2 (sd 10.8) at two years postoperatively (p < 0.001). All patients had radiologically well-fixed components, no patients experienced any instability, and no patients required any further intervention. Mean cobalt levels increased from 0.065 ug/l (sd 0.03) preoperatively to 0.30 ug/l (sd 0.51) at one year postoperatively (p = 0.01) but decreased at two years postoperatively to 0.16 ug/l (sd 0.23; p = 0.2). Four patients (9.3%) had a cobalt level outside the reference range (0.03 ug/l to 0.29 ug/l) at two years postoperatively, with values from 0.32 ug/l to 0.94 ug/l. The mean femoral BMD ratio was maintained in Gruen zones 2 to 7 at both one and two years postoperatively using this stem design. At two years postoperatively, mean BMD in the medial calcar was 101.5% of the baseline value.
Use of a modular DM prosthesis and cementless, tapered femoral stem has shown encouraging results in young, active patients undergoing primary THA. Elevation in mean cobalt levels and the presence of four patients outside the reference range at two years postoperatively demonstrates the necessity of continued surveillance in this cohort. Cite this article: Bone Joint J 2019;101-B:365-371.
在双动(DM)假体中,钴铬衬垫插入钛髋臼壳(而非整体髋臼组件),其优势在于可以增加螺钉固定,但衬垫和髋臼之间存在潜在的腐蚀问题。DM 假体在被认为存在脱位高风险的患者中(行全髋关节置换术,THA)显示出更好的稳定性,但在年轻、活跃的患者中的表现尚未有报道。本研究的目的是评估年轻、活跃的患者接受模块化 DM 髋臼和最近引入的钛近端涂层、锥形股骨柄设计后的临床结果、金属离子水平和假体周围股骨骨密度(BMD)。
这是一项前瞻性研究,纳入了年龄在 18 至 65 岁之间、体重指数(BMI)<35kg/m2 和加利福尼亚大学洛杉矶分校(UCLA)活动评分>6 的患者,他们接受了模块化钴铬髋臼衬垫、高交联聚乙烯活动衬垫和非骨水泥钛股骨柄作为初次 THA。排除有肾脏疾病病史和体内其他金属植入物的患者。共有 43 例患者(30 例男性,13 例女性;平均年龄 52.6 岁,标准差 6.5)入组。所有患者均获得至少 2 年的临床随访。患者报告的结果测量、全血金属离子水平(μg/l)和假体周围股骨 BMD 在基线时以及术后 1 年和 2 年均进行测量。根据统计学分析的需要,我们确定需要 40 例患者来证明钴水平从基线增加 5 倍(α=0.05,β=0.80)。采用重复测量混合模型进行统计学分析。
术后 2 年,Harris 髋关节评分从 54.1(标准差 20.5)提高至 91.2(标准差 10.8)(p<0.001)。所有患者的假体均固定良好,无患者出现不稳定,也无需进一步干预。钴水平从术前的 0.065μg/l(标准差 0.03)升高至术后 1 年的 0.30μg/l(标准差 0.51)(p=0.01),但术后 2 年降至 0.16μg/l(标准差 0.23;p=0.2)。术后 2 年,4 例(9.3%)患者的钴水平超出参考范围(0.03μg/l 至 0.29μg/l),范围为 0.32μg/l 至 0.94μg/l。使用该股骨柄设计,术后 1 年和 2 年时,在区域 2 至 7 ,股骨 BMD 比值均保持稳定。术后 2 年,内侧骨嵴的 BMD 平均值为基线值的 101.5%。
在年轻、活跃的患者中,使用模块化 DM 假体和非骨水泥、锥形股骨柄的初次 THA 取得了令人鼓舞的结果。钴水平升高以及术后 2 年时 4 例患者超出参考范围表明,该队列仍需要继续监测。