与一种独特的非骨水泥型股骨柄设计相关的假体周围股骨骨折风险增加。
Increased risk of periprosthetic femur fractures associated with a unique cementless stem design.
作者信息
Watts Chad D, Abdel Matthew P, Lewallen David G, Berry Daniel J, Hanssen Arlen D
机构信息
Department of Orthopedic Surgery, Mayo Clinic, 200 First Street SW, Mayo Clinic, Rochester, MN, 55905, USA.
出版信息
Clin Orthop Relat Res. 2015 Jun;473(6):2045-53. doi: 10.1007/s11999-014-4077-9. Epub 2014 Dec 12.
BACKGROUND
Postoperative periprosthetic femur fractures are an increasing concern after primary total hip arthroplasty (THA). Identifying and understanding predisposing factors are important to mitigating future risk. Femoral stem design may be one such factor.
QUESTIONS/PURPOSES: The goals of our study were to compare the (1) frequency of periprosthetic femur fracture and implant survivorship; (2) time to fracture in those patients who experienced periprosthetic femur fracture; and (3) predictive risk factors for periprosthetic femur fracture between a unique stem design with an exaggerated proximal taper angle and other contemporary cementless, proximally fixed, tapered stems.
METHODS
We reviewed all hips in which a femoral hip component with a uniquely exaggerated proximal taper angle (ProxiLock) was implanted during primary THA at a single academic institution. That group of patients was compared with a cohort of patients who underwent primary THA during the same time interval (1995-2008) in which any other cementless, proximally fixed, tapered stem design was used. The two groups differed somewhat in terms of sex, age, and body mass index, although these differences were of unclear clinical significance. During the study, 3964 primary THAs were performed using six different designs of cementless, proximally fixed, tapered femoral hip prostheses. There were 736 stems in the ProxiLock (PL) patient group and 3228 stems in the non-ProxiLock (non-PL) group. In general, the stem highlighted in this study became the routine cementless stem used for primary THA for three arthroplasty surgeons without specific patient or radiographic indications. Periprosthetic fractures were identified within each group. The incidence, timing, type, and treatment required for each fracture were analyzed. The Kaplan-Meier method was used to determine study patient survival free of any postoperative fracture. Radiographs and the electronic medical record of each patient who sustained a fracture were reviewed. Followup was comparable between groups at all time points.
RESULTS
The Kaplan-Meier estimate for fracture-free patient survival was worse in the PL group at all time points with survival of 98.4% (range, 97.4%-99.3%), 97.1% (range, 95.9%-98.3%), 95.4% (range, 93.8%-97.0%), and 92.6% (range, 89.6%-95.3%) at 30 days, 1 year, 5 years, and 10 years, respectively, for the PL patient group compared with 99.8% (range, 99.7%-99.9%), 99.6% (range, 99.3%-99.8%), 99.3% (range, 99.0%-99.6%), and 98.4% (range, 97.5%-99.1%) in the non-PL patient group (p < 0.001). Patients in the PL group had increased cumulative probability of both early and late fractures with cumulative probabilities of fracture of 2.5% (range, 1.3%-3.6%) at 90 days and 7.4% (range, 4.7%-10.4%) at 10 years compared with probabilities of 0.3% (range, 0.1%-0.5%) at 90 days and 1.6% (range, 0.8%-2.5%) at 10 years in the non-PL group (p < 0.001). Patients in the PL group had an increased risk of postoperative periprosthetic femur fracture (hazard ratio [HR], 5.6; 95% confidence interval [CI], 3.4-9.1; p < 0.001); fracture requiring reoperation (HR, 8.4; 95% CI, 4.4-15.9); p < 0.001); and fracture requiring stem revision (HR, 9.1; 95% CI, 4.5-18.5; p < 0.001). Age older than 60 years was also a risk factor for fracture (HR, 3.7; 95% CI, 2.1-6.4), but sex, body mass index, and preoperative diagnosis were not predictive.
CONCLUSIONS
Hips implanted with an uncemented femoral stem, which has a uniquely exaggerated proximal taper angle, had an increased risk of both early and late postoperative periprosthetic femur fracture. The majority of patients with a fracture underwent reoperation or stem revision. The unique proximal geometry, lack of axial support from the smooth cylindrical distal stem as well as resorption of the hydroxyapatite coating and poor ongrowth with subsequent subsidence may contribute to increased risk of fracture. Although this particular stem has recently been discontinued by the manufacturer, these findings are important in regard to followup care for patients with this stem implanted as well as for future cementless stem design in general.
LEVEL OF EVIDENCE
Level III, therapeutic study.
背景
初次全髋关节置换术(THA)后,术后假体周围股骨骨折日益受到关注。识别并了解诱发因素对于降低未来风险至关重要。股骨柄设计可能是其中一个因素。
问题/目的:我们研究的目的是比较:(1)假体周围股骨骨折的发生率和植入物生存率;(2)发生假体周围股骨骨折的患者的骨折时间;(3)一种近端锥角过大的独特柄设计与其他当代非骨水泥型、近端固定的锥形柄之间假体周围股骨骨折的预测风险因素。
方法
我们回顾了在一家学术机构进行初次THA时植入了近端锥角独特增大的股骨髋部组件(ProxiLock)的所有髋关节。将该组患者与在同一时间段(1995 - 2008年)接受初次THA且使用任何其他非骨水泥型、近端固定的锥形柄设计的患者队列进行比较。两组在性别、年龄和体重指数方面存在一定差异,尽管这些差异的临床意义尚不清楚。在研究期间,使用六种不同设计的非骨水泥型、近端固定的锥形股骨髋假体进行了3964例初次THA。ProxiLock(PL)患者组有736个股骨柄,非ProxiLock(非PL)组有3228个股骨柄。总体而言,本研究中突出的股骨柄成为三位关节置换外科医生在无特定患者或影像学指征情况下用于初次THA的常规非骨水泥型股骨柄。在每组中识别假体周围骨折。分析每次骨折的发生率、时间、类型和所需治疗。采用Kaplan - Meier方法确定无任何术后骨折的研究患者生存率。对发生骨折的每位患者的X线片和电子病历进行了回顾。各时间点两组的随访情况具有可比性。
结果
PL组在所有时间点的无骨折患者生存的Kaplan - Meier估计值均较差,PL患者组在30天、1年、5年和10年时的生存率分别为98.4%(范围97.4% - 99.3%)、97.1%(范围95.9% - 98.3%)、95.4%(范围93.8% - 97.0%)和92.6%(范围89.6% - 95.3%),而非PL患者组分别为99.8%(范围99.7% - 99.9%)、99.6%(范围99.3% - 99.8%)、99.3%(范围99.0% - 99.6%)和98.4%(范围97.5% - 99.1%)(p < 0.001)。PL组患者早期和晚期骨折的累积概率均增加,90天时骨折累积概率为2.5%(范围1.3% - 3.6%),10年时为7.4%(范围4.7% - 10.4%),相比之下非PL组90天时为0.3%(范围0.1% - 0.5%),10年时为1.6%(范围0.8% - 2.5%)(p < 0.001)。PL组患者术后假体周围股骨骨折风险增加(风险比[HR],5.6;95%置信区间[CI],3.4 - 9.1;p < 0.001);需要再次手术的骨折(HR,8.4;95% CI,4.4 - 15.9;p < 0.001);以及需要股骨柄翻修的骨折(HR,9.1;95% CI,4.5 - 18.5;p < 0.001)。60岁以上也是骨折的一个风险因素(HR,3.7;95% CI,2.1 - 6.4),但性别、体重指数和术前诊断无预测性。
结论
植入近端锥角独特增大的非骨水泥型股骨柄的髋关节术后早期和晚期假体周围股骨骨折风险增加。大多数骨折患者接受了再次手术或股骨柄翻修。独特的近端几何形状、光滑圆柱形远端柄缺乏轴向支撑以及羟基磷灰石涂层的吸收和随后下沉时的骨长入不良可能导致骨折风险增加。尽管该制造商最近已停产这种特定的股骨柄,但这些发现对于植入该股骨柄的患者的随访护理以及一般未来非骨水泥型股骨柄设计而言都很重要。
证据水平
III级,治疗性研究。
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