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美国合成软骨植入治疗僵硬拇趾的早期结果和并发症。

Early Outcomes and Complications of Synthetic Cartilage Implant for Treatment of Hallux Rigidus in the United States.

机构信息

Cedars-Sinai Medical Center, Los Angeles, CA, USA.

出版信息

Foot Ankle Int. 2019 Oct;40(10):1140-1148. doi: 10.1177/1071100719855049. Epub 2019 Jun 13.

Abstract

BACKGROUND

The aim of this study was to determine the early outcomes and complications following the implantation of a hydrogel synthetic cartilage implant (SCI, Cartiva) for the treatment of hallux rigidus by a single surgeon.

METHODS

A retrospective chart review was performed of consecutive patients who underwent treatment for hallux rigidus with an SCI between August 2016 and April 2018 by a single surgeon. Demographic information, radiographic assessment, and concomitant operative procedures performed were evaluated for all patients. Postoperatively, PROMIS physical function (PF) and pain interference (PI) scores, patient satisfaction, reoperation, conversion to arthrodesis, and need for further clinical treatment were collected. Sixty-four SCIs were implanted in 60 patients. Follow-up averaged 18.5 months (range 12-30 months).

RESULTS

14% (9/64) of patients were very satisfied, 28% (18/64) satisfied, 20% (13/64) neutral, 11% (7/64) unsatisfied, and 27% (17/64) very unsatisfied with their outcome. In addition, 45% of patients underwent additional procedures at the time of SCI, and 23% had a history of surgery on the hallux before implantation. PROMIS PF scores averaged 42 and PROMIS PI scores averaged 60. Overall, 63% completed PROMIS PI, 66% completed PROMIS PF, and 100% completed a satisfaction survey. In addition, 30% (19/64) underwent magnetic resonance imaging (MRI) postoperatively due to pain. There was a 20% reoperation rate, which included an 8% rate of conversion to arthrodesis.

CONCLUSION

Synthetic cartilage implantation yielded neutral patient satisfaction, mild pain, and physical dysfunction at early follow-up. We believe patient selection and counseling regarding early postoperative limitations are important before proceeding with SCI.

LEVEL OF EVIDENCE

Level IV, case series.

摘要

背景

本研究的目的是确定由一位外科医生植入水凝胶合成软骨植入物(SCI,Cartiva)治疗僵硬拇趾的早期结果和并发症。

方法

对 2016 年 8 月至 2018 年 4 月期间由一位外科医生连续治疗僵硬拇趾的患者进行回顾性图表审查。对所有患者的人口统计学信息、影像学评估和同时进行的手术操作进行评估。术后收集患者的 PROMIS 躯体功能(PF)和疼痛干扰(PI)评分、患者满意度、再次手术、转换为融合术以及是否需要进一步临床治疗的情况。共植入 64 个 SCI,涉及 60 例患者。平均随访 18.5 个月(12-30 个月)。

结果

14%(9/64)的患者非常满意,28%(18/64)满意,20%(13/64)中立,11%(7/64)不满意,27%(17/64)非常不满意。此外,45%的患者在植入 SCI 时同时进行了其他手术,23%的患者在植入前有拇趾手术史。PROMIS PF 评分平均为 42,PROMIS PI 评分平均为 60。总体而言,63%的患者完成了 PROMIS PI,66%的患者完成了 PROMIS PF,100%的患者完成了满意度调查。此外,由于疼痛,30%(19/64)的患者术后接受了磁共振成像(MRI)检查。再手术率为 20%,其中融合术转换率为 8%。

结论

合成软骨植入物在早期随访时产生了中立的患者满意度、轻度疼痛和躯体功能障碍。我们认为在进行 SCI 之前,患者的选择和关于术后早期限制的咨询很重要。

证据等级

IV 级,病例系列。

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