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自体软骨细胞移植治疗膝关节症状性软骨损伤并不优于关节镜下清创术:一项随机对照试验的两年结果

Autologous Chondrocyte Implantation Is Not Better Than Arthroscopic Debridement for the Treatment of Symptomatic Cartilage Lesions of the Knee: Two-Year Results From a Randomized-Controlled Trial.

作者信息

Randsborg Per-Henrik, Brinchmann Jan E, Owesen Christian, Engebretsen Lars, Birkenes Thomas, Hanvold Heidi Andreassen, Benth Jūratė Šaltytė, Årøen Asbjørn

机构信息

Department of Orthopaedic Surgery, Akershus University Hospital, Lørenskog, Norway.

Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Norway.

出版信息

Arthrosc Sports Med Rehabil. 2024 Feb 16;6(2):100909. doi: 10.1016/j.asmr.2024.100909. eCollection 2024 Apr.

Abstract

PURPOSE

To compare the functional and patient-reported outcome measures after autologous chondrocyte implantation (ACI) and arthroscopic debridement (AD) in symptomatic, isolated cartilage injuries larger than 2 cm in patients aged 18 to 50 years.

METHODS

Twenty-eight patients were included and randomized to ACI (n = 15) or AD (n = 13) and followed for 2 years. The primary outcome was the change in the Knee injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QoL) subscale.

RESULTS

The mean age at inclusion was 34.1 (standard deviation [SD] 8.5) years. There were 19 (68%) male patients. The mean size of the lesion was 4.2 (SD 1.7) cm. There was a statistically significant and clinically meaningful improvement in patient-reported outcome measures from baseline to 2 years in both groups. The improvement from baseline to final follow-up for the primary endpoint (the KOOS QoL subscale) was larger for the AD group (39.8, SD 9.4) compared with the ACI group (23.8, SD 6.7), but this difference was not statistically significant ( = .17). However, according to a mixed linear model there were statistically significantly greater scores in the AD group for several KOOS subscales at several time points, including KOOS QoL, KOOS pain, and KOOS sport and recreation at 2 years.

CONCLUSIONS

This study indicates that AD followed by supervised physiotherapy is equal to or better than ACI followed by supervised physiotherapy in patients with isolated cartilage lesions of the knee larger than 2 cm. The improvement in KOOS QoL score from baseline to 2 years was clinically meaningful for both groups (23.8 points for ACI and 39.8 points AD), and larger for the AD group by 16 points.

LEVEL OF EVIDENCE

Level I, prospective randomized controlled trial.

摘要

目的

比较18至50岁有症状的、孤立性软骨损伤大于2厘米的患者,在接受自体软骨细胞植入(ACI)和关节镜下清创术(AD)后的功能及患者报告的结局指标。

方法

纳入28例患者,随机分为ACI组(n = 15)或AD组(n = 13),随访2年。主要结局指标为膝关节损伤和骨关节炎结局评分(KOOS)生活质量(QoL)子量表的变化。

结果

纳入时的平均年龄为34.1(标准差[SD] 8.5)岁。男性患者19例(68%)。病变的平均大小为4.2(SD 1.7)厘米。两组患者从基线到2年的患者报告结局指标均有统计学意义且具有临床意义的改善。主要终点(KOOS QoL子量表)从基线到最终随访的改善,AD组(39.8,SD 9.4)大于ACI组(23.8,SD 6.7),但差异无统计学意义(P = 0.17)。然而,根据混合线性模型,AD组在多个时间点的几个KOOS子量表上的得分在统计学上显著更高,包括2年时的KOOS QoL、KOOS疼痛以及KOOS运动和娱乐。

结论

本研究表明,对于膝关节孤立性软骨损伤大于2厘米的患者,AD联合监督下的物理治疗等同于或优于ACI联合监督下的物理治疗。两组从基线到2年KOOS QoL评分的改善均具有临床意义(ACI组为23.8分,AD组为39.8分),且AD组比ACI组高16分。

证据级别

I级,前瞻性随机对照试验。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2c84/10943062/24f2b73e7706/gr1.jpg

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