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髌软骨缺损 ACI 的临床结果和成功率:一项对照随机临床二期试验(CODIS 研究)的亚组分析。

Clinical outcome and success rates of ACI for cartilage defects of the patella: a subgroup analysis from a controlled randomized clinical phase II trial (CODIS study).

机构信息

Department of Orthopedic Surgery and Traumatology, Freiburg University Hospital, Germany and OCM Clinic, OCM | Orthopädische Chirurgie München, Steinerstrass 6, 83069, Munich, Germany.

Joint and Spine Centre, Berlin, Germany.

出版信息

Arch Orthop Trauma Surg. 2020 Jun;140(6):717-725. doi: 10.1007/s00402-019-03264-x. Epub 2019 Aug 26.

Abstract

AIM

Cartilage defects of the patella are considered as a problematic entity. Purpose of the present study was to evaluate the outcome of patients treated with autologous chondrocyte implantation (ACI) for cartilage defects of the patella in comparison to patient with defects of the femoral condyles.

PATIENTS AND METHODS

73 patients with a follow-up of 5 years have been included in this subgroup analysis of the randomized controlled clinical trial (RCT). In dependence of defect location, patients were divided into two groups [patella defects (n = 45) and femoral condyle defects (n = 28)]. Clinical outcome was evaluated by the means of the KOOS score at baseline and 6 weeks, 3, 6, 12, 18, 24, 36, 48 and 60 months following ACI.

RESULTS

"Responder rate" at 60 months (improvement from baseline of > 7 points in the KOOS score) in patients with patella defects was 86.2%. All scores showed a significant improvement from baseline. While overall KOOS score at 60 months was 81.9 (SD 18.6) points in femoral condyle defects, a mean of 82.6 (SD 14.0) was observed in patella defects (p = 0.2483).

CONCLUSION

ACI seems an appropriate surgical treatment for cartilage defects of the patella leading to a high success rate. In this study, the clinical outcome in patients with patellar defects was even better than the already excellent results in patients with defects of the femoral condyle even though the study included relatively large defect sizes for both groups (mean defect size 6.0 ± 1.7 and 5.4 ± 1.6 for femur and patella, respectively).

摘要

目的

髌骨的软骨缺损被认为是一个有问题的实体。本研究的目的是评估自体软骨细胞移植(ACI)治疗髌骨软骨缺损患者的结果,并与股骨髁缺损患者进行比较。

患者和方法

本亚组分析纳入了一项随机对照临床试验(RCT)的 73 例随访 5 年的患者。根据缺损部位,患者分为两组[髌骨缺损(n=45)和股骨髁缺损(n=28)]。在 ACI 后 6 周、3、6、12、18、24、36、48 和 60 个月,通过 KOOS 评分评估临床结果。

结果

髌骨缺损患者在 60 个月时的“应答率”(KOOS 评分改善>7 分)为 86.2%。所有评分均从基线显著改善。虽然股骨髁缺损患者在 60 个月时的总体 KOOS 评分为 81.9(SD 18.6)分,但髌骨缺损患者的平均评分为 82.6(SD 14.0)分(p=0.2483)。

结论

ACI 似乎是治疗髌骨软骨缺损的一种合适的手术方法,成功率高。在这项研究中,髌骨缺损患者的临床结果甚至优于股骨髁缺损患者已经非常出色的结果,尽管研究纳入了两组相对较大的缺损大小(股骨和髌骨的平均缺损大小分别为 6.0±1.7 和 5.4±1.6)。

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