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约翰·英索尔奖:采用患者特异性器械进行单髁膝关节置换术后无功能获益:一项随机试验

The John Insall Award: No Functional Benefit After Unicompartmental Knee Arthroplasty Performed With Patient-specific Instrumentation: A Randomized Trial.

作者信息

Ollivier Matthieu, Parratte Sebastien, Lunebourg Alexandre, Viehweger Elke, Argenson Jean-Noel

机构信息

Department of Orthopedics and Traumatology, Institute for Locomotion, St Marguerite Hospital, Aix-Marseille University, 270 Boulevard Sainte Marguerite, BP 29, 13274, Marseille, France.

Department of Pediatric Surgery, Timone Hospital, Aix-Marseille University, Marseille, France.

出版信息

Clin Orthop Relat Res. 2016 Jan;474(1):60-8. doi: 10.1007/s11999-015-4259-0.

Abstract

BACKGROUND

Component alignment can influence implant longevity as well as perhaps pain and function after unicompartmental knee arthroplasty (UKA), but correct alignment is not consistently achieved. To increase the likelihood that good alignment will be achieved during surgery, smart tools such as robotics or patient-specific instrumentation (PSI) have been introduced.

QUESTIONS/PURPOSES: We hypothesized that UKA performed with PSI would result in improved level gait as ascertained with three-dimensional analysis, implant positioning, and patient-reported outcomes measured by a validated scoring system when compared with conventional instrumentation 3 months and 1 year after surgery.

METHODS

We randomized 60 patients into two groups using either the PSI technique or a conventional technique. All patients were operated on using the same technique and the same cemented metal-backed implant. Mean age of the patients was 63 ± 4 years (range, 54-72 years) and mean body mass index was 28 ± 3 kg/m(2). Patients were evaluated preoperatively, at 3 months, and 1 year after surgery by an independent observer blind to the type of technique. Gait parameters were assessed with three-dimensional analysis during level walking preoperatively and at 1 year, frontal and sagittal position of the implant was evaluated on full-length radiographs at 3 months, and subjective functional outcome and quality of life using routine questionnaires (SF-12, new Knee Society Score [KSS], Knee Injury and Osteoarthritis Outcome Score) at 3 months and 1 year. This study had 80% power to detect a 15% difference in walking speed at the p < 0.05 level.

RESULTS

One year after surgery, there were no differences between the two groups in the analyzed gait spatiotemporal parameters, respectively, for PSI UKA and conventional UKA : double limb support 31% (25%-54%) versus 30% (23%-56%; p = 0.67) and walking speed (1.59 m/s [0.86-1.87 m/s] versus 1.57 m/s [0.71-1.96 m/s]; p = 0.41). No difference was observed between the two groups in terms of lower limb alignment (PSI group 178° ± 3°, conventional group 178° ± 4°; p = 0.24) or implant positioning on mediolateral and anteroposterior radiographs. There were no differences in the functional score between the PSI and conventional TKA groups at 3 months and 1 year after surgery: KSS objective knee scores (PSI: 85 ± 8 points at 3 months, 87 ± 5 points at 1 year and conventional instrumentation: 82 ± 8 points at 3 months 83 ± 6 points at 1 year; p = 0.10) and functional activity scores were similar in both group (PSI: 71 ± 12 points at 3 months and 74 ± 7 points at 1 year versus conventional group: 73 ± 11 points at 3 months and 75 ± 6 at 1 year; p = 0.9).

CONCLUSIONS

Our observations suggest that PSI may confer small, if any, advantage in alignment, pain, or function after UKA. This argument can therefore not be used to justify the extra cost and uncertainty related to this technique.

LEVEL OF EVIDENCE

Level I, therapeutic study.

摘要

背景

组件对线可影响单髁膝关节置换术(UKA)后的植入物使用寿命以及疼痛和功能,但并非总能实现正确对线。为了提高手术中实现良好对线的可能性,已引入了智能工具,如机器人技术或患者特异性器械(PSI)。

问题/目的:我们假设,与传统器械相比,使用PSI进行UKA手术,在术后3个月和1年时,通过三维分析确定的步态水平、植入物位置以及通过经过验证的评分系统测量的患者报告结局会得到改善。

方法

我们将60例患者随机分为两组,分别采用PSI技术或传统技术。所有患者均采用相同技术和相同的骨水泥固定金属背衬植入物进行手术。患者的平均年龄为63±4岁(范围54 - 72岁),平均体重指数为28±3kg/m²。由对技术类型不知情的独立观察者在术前、术后3个月和1年对患者进行评估。术前和术后1年在平地行走时通过三维分析评估步态参数,术后3个月在全长X线片上评估植入物的前后位和矢状位,在术后3个月和1年使用常规问卷(SF - 12、新的膝关节协会评分[KSS]、膝关节损伤和骨关节炎结局评分)评估主观功能结局和生活质量。本研究有80%的把握度在p<0.05水平检测出行走速度15%的差异。

结果

术后1年,PSI UKA组和传统UKA组在分析的步态时空参数方面无差异:双下肢支撑分别为31%(25% - 54%)和30%(23% - 56%;p = 0.67),行走速度(1.59m/s[0.86 - 1.87m/s]和1.57m/s[0.71 - 1.96m/s];p = 0.41)。两组在下肢对线(PSI组178°±3°,传统组178°±4°;p = 0.24)或内外侧和前后位X线片上的植入物位置方面均未观察到差异。术后3个月和1年,PSI组和传统TKA组的功能评分无差异:KSS客观膝关节评分(PSI组:术后3个月85±8分,术后1年87±5分;传统器械组:术后3个月82±8分,术后1年83±6分;p = 0.10),两组的功能活动评分相似(PSI组:术后3个月71±12分,术后1年74±7分;传统组:术后3个月73±11分,术后1年75±6分;p = 0.9)。

结论

我们的观察结果表明,PSI在UKA术后的对线、疼痛或功能方面可能仅具有微小优势(如果有的话)。因此,这一观点无法用于证明该技术相关的额外成本和不确定性是合理的。

证据级别

I级,治疗性研究。

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