使用迷你股中间肌或髌旁内侧入路技术的计算机辅助全膝关节置换术：一项前瞻性、随机、国际多中心试验。
Computer-assisted total knee arthroplasty using mini midvastus or medial parapatellar approach technique: A prospective, randomized, international multicentre trial.
作者信息
Feczko Peter, Engelmann Lutz, Arts Jacobus J, Campbell David
机构信息
Department Orthopaedic Surgery, Research School Capri, Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX, Maastricht, The Netherlands.
Heinrich-Braun-Krankenhaus Zwickau, Städtisches Klinikum, Zwickau, Germany.
出版信息
BMC Musculoskelet Disord. 2016 Jan 13;17:19. doi: 10.1186/s12891-016-0872-7.
BACKGROUND
Despite the growing evidence in the literature there is still a lack of consensus regarding the use of minimally invasive surgical technique (MIS) in total knee arthroplasty (TKA).
METHODS
A prospective, randomized, international multicentre trial including 69 patients was performed to compare computer-assisted TKA (CAS-TKA) using either mini-midvastus (MIS group) or standard medial parapatellar approach (conventional group). Patients from 3 centers (Maastricht, Zwickau, Adelaide) with end-stage osteoarthritis of the knee were randomized to either an MIS group with dedicated instrumentation or a conventional group to receive cruciate retaining CAS-TKA without patella resurfacing. The primary outcome was to compare post operative pain and range of motion (ROM). The secondary outcome was to measure the duration of surgery, blood loss, chair rise test, quadriceps strength, anterior knee pain, Knee Society Score (KSS),WOMAC scores, mechanical leg axis and component alignment.
RESULTS
Patients in the MIS group (3.97 ± 2.16) had significant more pain at 2 weeks than patients in the conventional group (2.77 ± 1.43) p = 0.003. There was no significant difference in any of the other primary outcome parameters. Surgery time was significantly longer (p < 0.001) and there were significantly higher blood loss (p = 0.002) in the MIS group as compared to the conventional group. The difference of the mean mechanical leg alignment between the groups was not statistically significant (-0.43° (95% CI -1.50-0.64); p = 0.43). There was no significant difference of component alignment between the two surgical groups with respect to flexion/extension (p = 0.269), varus/valgus (p = 0.653) or rotational alignment (p = 0.485) of the femur component and varus valgus alignment (p = 0.778) or posterior slope (p = 0.164) of the tibial component.
CONCLUSION
There was no advantage of the MIS approach compared to a conventional approach CAS-TKA in any of the primary outcome measurements assessed, however the MIS approach was associated with longer surgical time and greater blood loss. MIS-TKA in combination with computer navigation is safe in terms of implant positioning.
TRIAL REGISTRATION NUMBER
ClinicalTrials.gov NCT02625311 8 December 2015.
背景
尽管文献中的证据越来越多，但在全膝关节置换术（TKA）中使用微创外科技术（MIS）仍缺乏共识。
方法
进行了一项前瞻性、随机、国际多中心试验，纳入69例患者，以比较使用迷你股中肌入路（MIS组）或标准髌旁内侧入路（传统组）的计算机辅助全膝关节置换术（CAS-TKA）。来自3个中心（马斯特里赫特、茨维考、阿德莱德）的终末期膝关节骨关节炎患者被随机分为使用专用器械的MIS组或接受保留交叉韧带的CAS-TKA且不进行髌骨表面置换的传统组。主要结局是比较术后疼痛和活动范围（ROM）。次要结局是测量手术持续时间、失血量、从椅子上起身测试、股四头肌力量、膝关节前方疼痛、膝关节协会评分（KSS）、WOMAC评分、机械腿轴线和假体对线。
结果
MIS组患者在术后2周时的疼痛程度（3.97±2.16）显著高于传统组患者（2.77±1.43），p = 0.003。在任何其他主要结局参数方面均无显著差异。与传统组相比，MIS组的手术时间显著更长（p < 0.001），失血量也显著更高（p = 0.002）。两组之间平均机械腿对线的差异无统计学意义（-0.43°（95%CI -1.50 - 0.64）；p = 0.43）。在股骨假体的屈伸（p = 0.269）、内外翻（p = 0.653）或旋转对线（p = 0.485）以及胫骨假体的内外翻对线（p = 0.778）或后倾（p = 0.164）方面，两个手术组之间的假体对线无显著差异。
结论
在所评估的任何主要结局测量中，与传统入路的CAS-TKA相比，MIS入路均无优势，然而MIS入路与更长的手术时间和更多的失血量相关。就植入物定位而言，MIS-TKA联合计算机导航是安全的。
试验注册号
ClinicalTrials.gov NCT02625311 2015年12月8日。
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