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一项针对有症状的半月板缺损膝关节患者的半月板同种异体移植与个性化物理治疗的试点随机试验。

A pilot randomized trial of meniscal allograft transplantation versus personalized physiotherapy for patients with a symptomatic meniscal deficient knee compartment.

作者信息

Smith N A, Parsons N, Wright D, Hutchinson C, Metcalfe A, Thompson P, Costa M L, Spalding T

机构信息

University Hospitals Coventry and Warwickshire NHS Trust, Clifford Bridge Road, Coventry CV2 2DX, UK.

University of Warwick, Coventry, CV7 4AL, UK.

出版信息

Bone Joint J. 2018 Jan;100-B(1):56-63. doi: 10.1302/0301-620X.100B1.BJJ-2017-0918.R1.

DOI:10.1302/0301-620X.100B1.BJJ-2017-0918.R1
PMID:29305451
Abstract

AIMS

Meniscal allograft transplantation is undertaken to improve pain and function in patients with a symptomatic meniscal deficient knee compartment. While case series have shown improvements in patient reported outcome measures (PROMs), its efficacy has not been rigorously evaluated. This study aimed to compare PROMs in patients having meniscal transplantation with those having personalized physiotherapy at 12 months.

PATIENTS AND METHODS

A single-centre assessor-blinded, comprehensive cohort study, incorporating a pilot randomized controlled trial (RCT) was performed on patients with a symptomatic compartment of the knee in which a (sub)total meniscectomy had previously been performed. They were randomized to be treated either with a meniscal allograft transplantation or personalized physiotherapy, and stratified for malalignment of the limb. They entered the preference groups if they were not willing to be randomized. The Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score and Lysholm score and complications were collected at baseline and at four, eight and 12 months following the interventions.

RESULTS

A total of 36 patients entered the study; 21 were randomized and 15 chose their treatments. Their mean age was 28 years (range 17 to 46). The outcomes were similar in the randomized and preference groups, allowing pooling of data. At 12 months, the KOOS composite score (mean difference 12, p = 0.03) and KOOS subscales of pain (mean difference 15, p = 0.02) and activities of daily living (mean difference 18, p = 0.005) were significantly superior in the meniscal transplantation group. Other PROMs also favoured this group without reaching statistical significance. There were five complications in the meniscal transplantation and one in the physiotherapy groups.

CONCLUSION

This is the first study to compare meniscal allograft transplantation to non-operative treatment. The results provide the best quality evidence to date of the symptomatic benefits of meniscal allograft transplantation in the short term, but a multicentre RCT is required to investigate this question further. Cite this article: 2018;100-B:56-63.

摘要

目的

同种异体半月板移植旨在改善有症状的半月板缺失膝关节腔患者的疼痛和功能。虽然病例系列研究显示患者报告结局量表(PROMs)有所改善,但其疗效尚未得到严格评估。本研究旨在比较半月板移植患者与接受个性化物理治疗患者在12个月时的PROMs。

患者与方法

对曾行(次)全半月板切除术的有症状膝关节腔患者进行了一项单中心、评估者盲法的综合性队列研究,并纳入了一项初步随机对照试验(RCT)。他们被随机分为接受同种异体半月板移植或个性化物理治疗,并根据肢体对线不良进行分层。如果他们不愿意被随机分组,则进入偏好组。在基线以及干预后的4个月、8个月和12个月收集膝关节损伤和骨关节炎结局评分(KOOS)、国际膝关节文献委员会(IKDC)评分、Lysholm评分及并发症情况。

结果

共有36例患者进入研究;21例被随机分组,15例选择了治疗方式。他们的平均年龄为28岁(范围17至46岁)。随机分组组和偏好组的结果相似,因此可以合并数据。在12个月时,半月板移植组的KOOS综合评分(平均差值12,p = 0.03)、KOOS疼痛子量表(平均差值15,p = 0.02)和日常生活活动子量表(平均差值18,p = 0.005)明显更优。其他PROMs也更有利于该组,但未达到统计学意义。半月板移植组有5例并发症,物理治疗组有1例并发症。

结论

这是第一项比较同种异体半月板移植与非手术治疗的研究。结果提供了迄今为止关于同种异体半月板移植短期症状性益处的最佳质量证据,但需要多中心RCT进一步研究这个问题。引用本文:2018;100 - B:56 - 63。

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