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机器人辅助与手动植入初次全髋关节置换术的比较:一项前瞻性研究。

Comparison of robotic-assisted and manual implantation of a primary total hip replacement. A prospective study.

作者信息

Honl Matthias, Dierk Oliver, Gauck Christian, Carrero Volker, Lampe Frank, Dries Sebastian, Quante Markus, Schwieger Karsten, Hille Ekkehard, Morlock Michael M

机构信息

Department of Orthopaedic Surgery, Barmbek General Hospital, Hamburg, Germany.

出版信息

J Bone Joint Surg Am. 2003 Aug;85(8):1470-8. doi: 10.2106/00004623-200308000-00007.

Abstract

BACKGROUND

Robotic-assisted total hip replacement has become a common method of implantation, especially in Europe. It frequently has been postulated that robotic reaming would result in an improved clinical outcome due to the better fit of the prosthesis, but that has never been demonstrated in a prospective study, to our knowledge. The purpose of this study was to compare robotic-assisted implantation of a total hip replacement with conventional manual implantation.

METHODS

One hundred and fifty-four patients scheduled for total hip replacement were randomly assigned to undergo either conventional manual implantation of an S-ROM prosthesis (eighty patients) or robotic-assisted implantation of such a prosthesis (seventy-four patients). The five-axis ROBODOC was used for the robotic-assisted procedures. Preoperatively as well as at three, six, twelve, and twenty-four months after surgery, the scores according to the Harris and Merle d'Aubigné systems and the Mayo clinical score were determined. Radiographs made at these intervals were analyzed for evidence of loosening, prosthetic alignment, and heterotopic ossification.

RESULTS

Thirteen (18%) of the seventy-four attempted robotic implantations had to be converted to manual implantations as a result of failure of the system. The duration of the robotic procedures was longer than that of the manual procedures (mean and standard deviation,107.1 +/- 29.1 compared with 82.4 +/- 23.4 minutes, p < 0.001). Limb-length equality (mean discrepancy, 0.18 +/- 0.30 compared with 0.96 +/- 0.93 cm, p < 0.001) and varus-valgus orientation of the stem (mean angle between the femur and the shaft of the prosthesis, 0.34 degrees +/- 0.67 degrees compared with 0.84 degrees +/- 1.23 degrees, p < 0.001) were better after the robotic procedures. At six months, slightly more heterotopic ossification was seen in the group treated with robotic implantation. The group treated with robotic implantation had a better Mayo clinical score at six and twelve months and a better Harris score at twelve months; however, by twenty-four months, no difference was found between the groups with regard to any of the three scores. Dislocation was more frequent in the group treated with robotic implantation: it occurred in eleven of the sixty-one patients in that group compared with three of eighty in the other group (p < 0.001). Recurrent dislocation and pronounced limping were indications for revision surgery in eight of the sixty-one patients treated with robotic implantation compared with none of the seventy-eight (excluding two with revision for infection) treated with manual insertion (p < 0.001). Rupture of the gluteus medius tendon was observed during all of the revision operations.

CONCLUSIONS

The robotic-assisted technology had advantages in terms of preoperative planning and the accuracy of the intraoperative procedure. Disadvantages were the high revision rate; the amount of muscle damage, which we believe was responsible for the higher dislocation rate; and the longer duration of surgery. This technology must be further developed before its widespread usage can be justified.

摘要

背景

机器人辅助全髋关节置换术已成为一种常见的植入方法,尤其是在欧洲。人们常常推测,由于假体适配性更好,机器人扩髓会带来更好的临床效果,但据我们所知,这从未在前瞻性研究中得到证实。本研究的目的是比较机器人辅助全髋关节置换术与传统手工植入术。

方法

154例计划行全髋关节置换术的患者被随机分配,分别接受S-ROM假体的传统手工植入术(80例患者)或机器人辅助植入术(74例患者)。使用五轴ROBODOC进行机器人辅助手术。在术前以及术后3个月、6个月、12个月和24个月,根据Harris和Merle d'Aubigné系统以及Mayo临床评分进行评分。分析这些时间点拍摄的X线片,以观察松动、假体对线和异位骨化的情况。

结果

74例尝试的机器人植入手术中有13例(18%)因系统故障而不得不转为手工植入。机器人手术的持续时间比手工手术长(平均值和标准差,分别为107.1±29.1分钟和82.4±23.4分钟,p<0.001)。机器人手术后肢体长度相等情况更好(平均差异,分别为0.18±0.30厘米和0.96±0.93厘米,p<0.001),假体柄的内翻-外翻方向也更好(股骨与假体柄之间的平均角度,分别为0.34°±0.67°和0.84°±1.23°,p<0.001)。在6个月时,机器人植入治疗组的异位骨化稍多。机器人植入治疗组在6个月和12个月时Mayo临床评分更好,在12个月时Harris评分更好;然而,到24个月时,两组在这三项评分中的任何一项上均未发现差异。机器人植入治疗组脱位更频繁:该组61例患者中有11例发生脱位,而另一组80例中有3例发生脱位(p<0.001)。在接受机器人植入治疗的61例患者中,有8例因反复脱位和明显跛行而需要翻修手术,而接受手工植入的78例患者(不包括2例因感染而翻修的患者)中无一例需要翻修(p<0.001)。在所有翻修手术中均观察到臀中肌腱断裂。

结论

机器人辅助技术在术前规划和术中操作准确性方面具有优势。缺点是翻修率高;肌肉损伤量大,我们认为这是脱位率较高的原因;以及手术时间长。在该技术能够被广泛应用之前,必须进一步改进。

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