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Activ-L腰椎置换系统的长期临床疗效

Long-Term Clinical Outcomes With the Activ-L Lumbar Arthroplasty System.

作者信息

Bryant Jean-Paul, Kolcun John Paul G, Brusko G Damian, Wang Michael Y, Garcia Rolando

机构信息

Department of Neurological Surgery, University of Miami Miller School of Medicine, Miami, Florida.

Department of Neurological Surgery, Rush University Medical Center, Chicago, Illinois.

出版信息

Int J Spine Surg. 2020 Oct;14(5):731-735. doi: 10.14444/7105. Epub 2020 Oct 19.

Abstract

BACKGROUND

Low back pain (LBP) due to degenerative disc disease (DDD) is the most common occupational disorder worldwide. Lumbar total disc replacement (LTDR) has provided an alternative to rigid fusion to relieve pain with less motion restriction. We present clinical results with long-term follow-up from a single-center, single-surgeon series of patients treated with the Activ-L artificial disc.

METHODS

Thirty-three patients with symptomatic single-level DDD who failed nonsurgical therapy for a minimum of 6 months underwent single-level arthroplasty with the Activ-L system between 2007 and 2012. Demographic, preoperative, and postoperative data were collected prospectively. Clinical factors reviewed included occupational status, sensory deficits, functional status determined by Oswestry Disability Index (ODI), back pain, leg pain, pain medication consumption, and radiographic imaging.

RESULTS

Average age at surgery was 38.0 ± 7.8 years, and the majority of patients were male (60.6%). Average follow-up was 2.7 ± 1.7 years. Average ODI at preoperative baseline was 54.6 ± 13.5, with scores significantly improved at 6 weeks (28.6 ± 17.4, < .0001), 3 months (24.1 ± 16.8, < .0001), 6 months (22.3 ± 16.3, < .0001), 1 year (18.8 ± 15.3, < .0001), and final follow-up (15.6 ± 16.4, < .0001). Most patients (87.8%) reported pain medication usage within 14 days of baseline evaluation, with consumption decreasing significantly at 1-year (34.5%, < .0001) and long-term follow-up (21.2%, < .0001). One patient experienced mild unilateral graft subsidence at 1 year, which remained stable on radiographs at 5 years. None of the prostheses required revision surgery.

CONCLUSIONS

The Activ-L disc replacement system is safe and effective for treating single-level lumbar DDD. Patients reported significant improvement in functional outcomes and decreases in pain medication consumption. Further investigation of the Activ-L system in larger populations is warranted.

CLINICAL RELEVANCE

LBP is a common cause of disability worldwide, and better treatment options are needed to improve outcomes, including pain and mobility. Spine surgeons may choose the Activ-L disc replacement as a safe and effective treatment for LBP caused by single-level lumbar DDD.

摘要

背景

因椎间盘退变疾病(DDD)导致的下腰痛(LBP)是全球最常见的职业性疾病。腰椎全椎间盘置换术(LTDR)为刚性融合提供了一种替代方案,可在减少活动受限的情况下缓解疼痛。我们展示了采用Activ-L人工椎间盘治疗的单中心、单术者系列患者的长期随访临床结果。

方法

33例有症状的单节段DDD患者,非手术治疗至少6个月失败后,于2007年至2012年间接受了Activ-L系统单节段关节成形术。前瞻性收集人口统计学、术前和术后数据。审查的临床因素包括职业状况、感觉缺陷、由Oswestry功能障碍指数(ODI)确定的功能状态、背痛、腿痛、止痛药物使用情况以及影像学检查。

结果

手术时的平均年龄为38.0±7.8岁,大多数患者为男性(60.6%)。平均随访时间为2.7±1.7年。术前基线时ODI平均为54.6±13.5,在6周(28.6±17.4,P<0.0001)、3个月(24.1±16.8,P<0.0001)、6个月(22.3±16.3,P<0.0001)、1年(18.8±15.3,P<0.0001)和最终随访时(15.6±16.4,P<0.0001)分数显著改善。大多数患者(87.8%)在基线评估后14天内报告使用止痛药物,在1年时(34.5%,P<其0.0001)和长期随访时(21.2%,P<0.0001)使用量显著减少。1例患者在1年时出现轻度单侧移植物下沉,5年时X线片显示稳定。无一例假体需要翻修手术。

结论

Activ-L椎间盘置换系统治疗单节段腰椎DDD安全有效。患者报告功能结果显著改善,止痛药物使用量减少。有必要在更大人群中对Activ-L系统进行进一步研究。

临床意义

LBP是全球致残的常见原因,需要更好的治疗选择来改善包括疼痛和活动能力在内的结果。脊柱外科医生可选择Activ-L椎间盘置换术作为单节段腰椎DDD所致LBP的安全有效治疗方法。

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