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评估肱骨表面置换假体周围骨密度和术后迁移:一项随机对照临床试验的两年结果。

Evaluation of periprosthetic bone mineral density and postoperative migration of humeral head resurfacing implants: two-year results of a randomized controlled clinical trial.

机构信息

Department of Orthopaedics, University Hospital of Aarhus, Aarhus, Denmark.

Department of Orthopedic Surgery, Silkeborg Regional Hospital, Silkeborg, Denmark.

出版信息

J Shoulder Elbow Surg. 2014 Oct;23(10):1427-36. doi: 10.1016/j.jse.2014.05.012.

DOI:10.1016/j.jse.2014.05.012
PMID:25220196
Abstract

BACKGROUND

Implant migration, bone mineral density (BMD), length of glenohumeral offset (LGHO), and clinical results were compared for the Copeland (Biomet Inc, Warsaw, IN, USA) and the Global C.A.P. (DePuy Int, Warsaw, IN, USA) humeral head resurfacing implants (HHRIs).

METHODS

The study randomly allocated 32 patients (13 women), mean age 63 years (range, 39-82 years), with shoulder osteoarthritis to a Copeland (n = 14) or Global C.A.P. (n = 18) HHRI. Patients were monitored for 2 years with radiostereometry, dual-energy X-ray absorptiometry, Constant Shoulder Score (CSS), and the Western Ontario Osteoarthritis of the Shoulder Index (WOOS). LGHO was measured preoperatively and 6 months postoperatively.

RESULTS

At 2 years, total translation (TT) was 0.48 mm (standard deviation [SD], 0.21 mm) for the Copeland and 0.82 mm (SD, 0.46 mm) for the Global C.A.P. (P = .06). Five HHRI were revised, and in the interval before the last follow-up (revision or 2 years), TT of 0.58 mm (SD, 0.61 mm) for revised HHRI was higher (P = .02) than TT of 0.22 mm (SD, 0.17 mm) in nonrevised HHRI. A comparison of TT at the last follow-up (revision or 2 years) found no difference between the HHRIs (P = .12). Periprosthetic BMD decreased initially but increased continuously after 6 months for both HHRIs. At 2 years, BMD was 48% higher around the Copeland HHRI (P = .005). The mean difference in LGHO was significantly higher for the Copeland than for the Global C.A.P. HHRI (P = .02). Clinical results evaluated with CSS and WOOS improved over time for both implant groups (P < .01), with no differences between the groups.

CONCLUSION

Both implants had only little migration and good clinical results. Periprosthetic BMD and LGHO both increased for the Copeland HHRI more than for the Global C.A.P HHRI.

摘要

背景

对 Copeland(Biomet Inc,美国华沙)和 Global C.A.P.(DePuy Int,美国华沙)肱骨头表面置换假体(HHRIs)进行了假体迁移、骨密度(BMD)、肩肱距离(LGHO)和临床结果的比较。

方法

研究将 32 例(13 名女性)年龄平均 63 岁(范围 39-82 岁)的肩关节骨关节炎患者随机分配至 Copeland(n = 14)或 Global C.A.P.(n = 18)HHRI 组。使用放射立体测量术、双能 X 线吸收法、Constant 肩关节评分(CSS)和 Western Ontario 肩关节炎指数(WOOS)对患者进行了 2 年的监测。术前和术后 6 个月测量 LGHO。

结果

在 2 年时,Copeland 的总平移量(TT)为 0.48mm(标准差 [SD],0.21mm),Global C.A.P.的 TT 为 0.82mm(SD,0.46mm)(P =.06)。5 例 HHRIs 进行了翻修,在最后一次随访(翻修或 2 年)之前的间隔期内,翻修 HHRIs 的 TT 为 0.58mm(SD,0.61mm)(P =.02)高于非翻修 HHRIs 的 TT 0.22mm(SD,0.17mm)。比较最后一次随访(翻修或 2 年)时的 TT,两种 HHRIs 之间无差异(P =.12)。两种 HHRIs 的假体周围 BMD 最初均下降,但 6 个月后持续增加。2 年时,Copeland HHRIs 周围的 BMD 增加了 48%(P =.005)。Copeland 与 Global C.A.P. HHRIs 相比,LGHO 的平均差异显著更高(P =.02)。两组的 CSS 和 WOOS 临床结果均随时间推移而改善(P <.01),两组之间无差异。

结论

两种假体的迁移量均较小,临床效果良好。Copeland HHRIs 的假体周围 BMD 和 LGHO 均高于 Global C.A.P. HHRIs。

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