N. Nakamura, Center of Arthroplasty, Kyowakai Hospital, Osaka, Japan N. Sugano, T. Sakai, Department of Orthopedic Surgery, Osaka University Medical School, Osaka, Japan I. Nakahara, Department of Orthopedic Surgery, Osaka National Hospital, Osaka, Japan.
Clin Orthop Relat Res. 2018 Nov;476(11):2169-2173. doi: 10.1097/CORR.0000000000000467.
Robotic-assisted THA has been promoted as potentially advantageous due to the precision it may afford when machining the proximal femur. However, few reports have compared the long-term clinical results of robotic techniques for femoral component insertion during THA regarding clinical outcomes scores or loosening.
QUESTIONS/PURPOSES: The purpose of this study was to compare results from a randomized clinical trial (RCT) at a minimum followup of 10 years between robot-assisted and hand-rasped stem implantation techniques with regard to (1) Japanese Orthopaedic Association (JOA) clinical outcomes scores, and (2) aseptic loosening, revision surgery, and heterotopic ossification.
This is a concise followup of a previously reported RCT. In that trial, robot-assisted primary THA was performed on 75 hips (69 patients), and a hand-rasping technique was used on 71 hips (61 patients). Five experienced surgeons at two institutions participated in this trial; all THAs were performed through the posterolateral approach and the patients were treated similarly apart from the method used to prepare the femur. In all, 115 of 130 (88%) of patients initially randomized were available for followup at a minimum of 10 years (mean, 135 months; range, 120-152 months). There was no differential loss to followup between the study groups, and the final study groups here included 64 hips in 59 patients in the robotic group, and 64 hips in 56 patients in the hand-milling group. There were no differences between the study groups in terms of age, sex, diagnosis, body-mass index, or baseline JOA scores. The primary study endpoint was the JOA score, which is scored from 0 to 100, with higher scores representing better function and less pain. Secondary outcomes were revision surgery, and radiographic signs of aseptic loosening and heterotopic ossification as assessed using the four-grade Brooker scale by individuals other than the operating surgeon.
At a minimum of 10 years postoperatively, there were no differences between patients treated with robot-assisted surgery or hand rasping in JOA scores (97 ± 5 versus 96 ± 7, mean difference 1.4; p = 0.159). No stems in either group developed aseptic loosening, and there were no revisions in either group. There was no difference between the groups in heterotopic ossification (19 of 64 [30%] in the robot-assisted group versus 12 of 64 [19%] in the hand-rasping group; p = 0.186), severe heterotopic ossification was uncommon in both groups, and no hips developed Grade 4 heterotopic ossification in either group.
Clinically and radiographically, THAs performed with robotic milling for stem implantation did not result in better 10-year clinical outcomes scores, or a lower risk of loosening or revision, compared with hand-rasping. We recommend against widespread adoption of robotic milling for stem implantation in primary cementless THAs.
Level II, therapeutic study.
机器人辅助 THA 因其在加工股骨近端时可能具有的精度而被认为具有潜在优势。然而，很少有研究比较机器人技术和手动锉削技术在 THA 中股骨部件插入的长期临床结果，包括临床结果评分或松动。
问题/目的：本研究的目的是比较一项随机临床试验（RCT）的结果，该 RCT 在至少 10 年的随访中，比较机器人辅助和手动锉削技术在（1）日本矫形协会（JOA）临床结果评分，以及（2）无菌性松动、翻修手术和异位骨化方面的结果。
这是先前报道的 RCT 的简明随访。在该试验中，对 75 髋（69 例）进行了机器人辅助初次 THA，对 71 髋（61 例）采用了手动锉削技术。两个机构的 5 名经验丰富的外科医生参与了这项试验；所有 THA 均通过后外侧入路进行，除了股骨准备方法外，患者的治疗方法相似。最初随机分配的 130 例中有 115 例（88%）至少随访 10 年（平均 135 个月；范围 120-152 个月）。研究组之间没有差异导致随访丢失，最终的研究组包括机器人组的 59 例中的 64 髋，以及手动锉削组的 56 例中的 64 髋。两组之间在年龄、性别、诊断、体重指数或基线 JOA 评分方面无差异。主要研究终点是 JOA 评分，评分为 0 至 100 分，分数越高表示功能越好，疼痛越少。次要结果是翻修手术，以及由非手术医生使用四级布鲁克量表评估的无菌性松动和异位骨化的影像学迹象。
至少 10 年后，机器人辅助手术和手动锉削治疗的患者在 JOA 评分方面没有差异（97 ± 5 与 96 ± 7，平均差异 1.4；p = 0.159）。两组均无假体无菌性松动，也无翻修。两组之间的异位骨化没有差异（机器人组 64 例中的 19 例[30%]与手动锉削组 64 例中的 12 例[19%]；p = 0.186），两组中严重异位骨化都不常见，也没有任何髋关节出现 4 级异位骨化。
临床和影像学结果表明，与手动锉削相比，机器人铣削用于股骨柄植入的 THA 并不能获得更好的 10 年临床结果评分，也不能降低松动或翻修的风险。我们不建议在初次非骨水泥 THA 中广泛采用机器人铣削进行股骨柄植入。
II 级，治疗性研究。
