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Subchondroplasty® 治疗骨关节炎骨髓病变的安全性和早期结果:系统评价。

Safety and early results of Subchondroplasty® for the treatment of bone marrow lesions in osteoarthritis: a systematic review.

机构信息

Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada.

Faculty of Science, Western University, London, ON, Canada.

出版信息

Knee Surg Sports Traumatol Arthrosc. 2021 Nov;29(11):3599-3607. doi: 10.1007/s00167-020-06294-w. Epub 2020 Sep 29.

Abstract

PURPOSE

Subchondroplasty® is a novel minimally invasive procedure for painful subchondral bone marrow lesions (BMLs). The aim of this systematic review was to characterize the clinical outcomes of the Subchondroplasty® procedure, a novel minimally invasive procedure for the treatment of BMLs. The hypothesis tested was that patients experience improvements in pain and functional outcomes following the Subchondroplasty® procedure.

METHODS

MEDLINE, Embase, Web of Science, and Clinicaltrials.gov were searched from database inception to search date (June 10, 2020) for all clinical studies which discussed Subchondroplasty®. Two reviewers independently screened 45 unique results and 17 studies were included in the final analysis. Data were collected regarding patient demographics, indications, pain, functional scores, conversion to TKA, and complications of the procedure.

RESULTS

All but one study were level IV evidence; the mean MINORS score was 9 ± 2. There were 756 patients included, 45.1% were female, and the mean age was 54 years (range 20-85). Thirteen studies investigated the effect Subchondroplasty® to the knee, while four studied the impact on the foot and ankle. Median length of follow-up was 12 months. The most common indication for Subchondroplasty® was joint pain with corresponding BML. Major contraindications to Subchondroplasty® included severe OA, joint instability, and malalignment. Mean pain score on visual analogue scale (VAS) prior to Subchondroplasty® was 7.8 ± 0.6, but decreased to 3.4 ± 0.7 postoperatively. All studies investigating functional scores reported improvement following Subchondroplasty® (IKDC 31.7 ± 1.9-54.0 ± 4.2 and KOOS 38.1 ± 0.6-70.0 ± 4.1). There were consistently high levels of patient satisfaction; 87 ± 8% of patients would be willing to undergo the procedure again. Seven cases of complications were reported, most seriously osteomyelitis and avascular necrosis. Conversion to knee arthroplasty ranged from 12.5 to 30% with length of follow-up ranging from 10 months to 7 years.

CONCLUSIONS

Existing low-quality studies show Subchondroplasty® to benefit patients with BMLs through reduction in pain and improvement in function, along with a high degree of satisfaction following the procedure. The low short-to-medium term conversion rate to arthroplasty suggests that Subchondroplasty® may play a role in delaying more invasive and expensive procedures in patients with BMLs. Subchondroplasty® is a novel procedure that has promising initial findings, but requires further high-quality, comparative studies with long-term follow-up to better understand the outcomes of the procedure and impact clinical practice recommendations.

LEVEL OF EVIDENCE

Systematic Review of Level III and IV Studies, Level IV.

摘要

目的

Subchondroplasty® 是一种治疗骨软骨下骨髓病变(BML)的新型微创方法。本系统评价的目的是描述 Subchondroplasty® 治疗 BML 的临床效果,假设是患者在接受 Subchondroplasty® 治疗后疼痛和功能结局得到改善。

方法

从数据库创建开始到 2020 年 6 月 10 日,在 MEDLINE、Embase、Web of Science 和 Clinicaltrials.gov 上搜索了所有讨论 Subchondroplasty® 的临床研究。两名评审员独立筛选了 45 个独特的结果,最终有 17 项研究纳入了最终分析。数据收集了患者的人口统计学、适应证、疼痛、功能评分、向 TKA 的转换以及手术并发症。

结果

除了一项研究外,其余均为 IV 级证据;平均 MINORS 评分为 9±2。共纳入 756 例患者,45.1%为女性,平均年龄为 54 岁(20-85 岁)。13 项研究调查了 Subchondroplasty® 对膝关节的影响,4 项研究调查了对足踝的影响。中位随访时间为 12 个月。Subchondroplasty® 的最常见适应证是关节疼痛伴相应的 BML。Subchondroplasty® 的主要禁忌证包括严重 OA、关节不稳定和对线不良。Subchondroplasty® 术前 VAS 平均疼痛评分 7.8±0.6,但术后降至 3.4±0.7。所有研究报告功能评分均有改善(IKDC 31.7±1.9-54.0±4.2 和 KOOS 38.1±0.6-70.0±4.1)。患者满意度始终很高;87±8%的患者愿意再次接受该手术。报告了 7 例并发症,最严重的是骨髓炎和骨坏死。膝关节置换的转化率为 12.5%至 30%,随访时间为 10 个月至 7 年。

结论

现有低质量研究表明,Subchondroplasty® 通过减轻疼痛和改善功能使 BML 患者受益,并且术后满意度很高。短期至中期向关节置换术的低转化率表明,Subchondroplasty® 可能在延迟 BML 患者更具侵入性和昂贵的治疗方法方面发挥作用。Subchondroplasty® 是一种有前途的新型手术方法,但需要进一步进行高质量、长期随访的比较研究,以更好地了解手术结果并影响临床实践建议。

证据水平

III 级和 IV 级研究的系统评价,IV 级。

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