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关节腔内注射骨髓抽吸浓缩物治疗髋膝关节早期骨关节炎的早期临床结果:一项队列研究

Early Clinical Outcomes of Intra-Articular Injections of Bone Marrow Aspirate Concentrate for the Treatment of Early Osteoarthritis of the Hip and Knee: A Cohort Study.

作者信息

Rodriguez-Fontan Francisco, Piuzzi Nicolas S, Kraeutler Matthew J, Pascual-Garrido Cecilia

机构信息

Regenerative Orthopedics Laboratory, Department of Orthopedics, University of Colorado Anschutz Medical Campus, Aurora, CO; and Facultad de Medicina, Universidad de Buenos Aires, Buenos Aires, Argentina(∗).

Department of Orthopaedic Surgery, Cleveland Clinic, Cleveland, OH; and Instituto Universitario del Hospital Italiano de Buenos Aires, Argentina(†).

出版信息

PM R. 2018 Dec;10(12):1353-1359. doi: 10.1016/j.pmrj.2018.05.016. Epub 2018 May 29.

DOI:10.1016/j.pmrj.2018.05.016
PMID:29857166
Abstract

BACKGROUND

Bone marrow aspirate concentrate (BMC) is one of the few cell-based therapies available as a possible biological treatment for early osteoarthritis (OA). Its efficacy, safety, and benefit compared with other treatments are still to be determined.

OBJECTIVE

To assess the clinical outcomes of patients undergoing intra-articular injection of BMC for the treatment of early knee and hip OA.

DESIGN

Prospective, cohort study.

SETTING

Single institution, quaternary level of care.

PATIENTS

Nineteen patients (16 female and 3 male), totaling 25 joints (10 knees, 15 hips), treated with intra-articular BMC for early OA between 2014 and 2016. The mean age at time of the procedure was 58 ± 12.7 years (range, 30-80 years). The mean follow-up was 13.2 ± 6.3 months (range, 6-24 months). Inclusion criteria included ≥18 years; knee OA, Kellgren-Lawrence grade I-II; hip OA, Tönnis grade I-II; first-time intra-articular BMC therapy, after unsuccessful symptomatic and conservative treatments (ie, physical therapy, analgesics and anti-inflammatory drugs) for 6 months. Exclusion criteria included pregnancy; malignancy; rheumatologic diseases; infection; Kellgren-Lawrence grade III-IV; Tönnis grade III; and previous intra-articular injections or surgery.

INTERVENTIONS

All patients had autologous bone marrow aspirate harvested from the iliac crest and centrifuged to achieve BMC, for intra-articular injection.

MAIN OUTCOME MEASUREMENTS

The hypothesis was formulated before the study. Patient-reported outcomes measures were assessed preoperatively and at last follow-up using the Western Ontario and McMaster Universities Arthritis Index.

RESULTS

Western Ontario and McMaster Universities Arthritis Index improved from a baseline of 40.8 ± 18.3% to 20.6 ± 17% (P < .001) at final follow-up. The satisfaction rate was 63.2%. The minimal clinically important difference threshold of 9.15 points was reached by 64% of the patients. Two patients were converted to total hip arthroplasty at 8 months after BMC injection.

CONCLUSIONS

Intra-articular injections of BMC for the treatment of early knee or hip OA were safe and demonstrated satisfactory results in 63.2% of patients. Future studies are necessary to determine the efficacy of this technique and its safety profile.

LEVEL OF EVIDENCE

II.

摘要

背景

骨髓抽吸浓缩物(BMC)是少数可用的基于细胞的疗法之一,作为早期骨关节炎(OA)的一种可能的生物治疗方法。与其他治疗方法相比,其疗效、安全性和益处仍有待确定。

目的

评估接受关节内注射BMC治疗早期膝和髋OA患者的临床结局。

设计

前瞻性队列研究。

设置

单一机构,四级护理水平。

患者

19例患者(16例女性,3例男性),共25个关节(10个膝关节,15个髋关节),于2014年至2016年间接受关节内BMC治疗早期OA。手术时的平均年龄为58±12.7岁(范围30 - 80岁)。平均随访时间为13.2±6.3个月(范围6 - 24个月)。纳入标准包括年龄≥18岁;膝关节OA,Kellgren-Lawrence分级I-II级;髋关节OA,Tönnis分级I-II级;首次关节内BMC治疗,在症状性和保守治疗(即物理治疗、镇痛药和抗炎药)6个月失败后。排除标准包括妊娠;恶性肿瘤;风湿性疾病;感染;Kellgren-Lawrence分级III-IV级;Tönnis分级III级;以及既往关节内注射或手术史。

干预措施

所有患者均从髂嵴采集自体骨髓抽吸物并离心获得BMC,用于关节内注射。

主要结局指标

在研究前提出假设。术前和末次随访时使用西安大略和麦克马斯特大学关节炎指数评估患者报告的结局指标。

结果

末次随访时,西安大略和麦克马斯特大学关节炎指数从基线的40.8±18.3%改善至20.6±17%(P <.001)。满意率为63.2%。64%的患者达到了9.15分的最小临床重要差异阈值。2例患者在BMC注射8个月后改行全髋关节置换术。

结论

关节内注射BMC治疗早期膝或髋OA是安全的,63.2%的患者显示出满意的结果。未来有必要进行研究以确定该技术的疗效及其安全性。

证据水平

II级。

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