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Bryan(®) 椎间盘假体治疗颈椎病的优越性:一项随机研究,随访 3 年。

Superiority of the Bryan(®) disc prosthesis for cervical myelopathy: a randomized study with 3-year followup.

机构信息

Department of Orthopaedics, Qilu Hospital, Shandong University, 107 West Wenhua Road, Jinan 250012, Shandong, China.

出版信息

Clin Orthop Relat Res. 2011 Dec;469(12):3408-14. doi: 10.1007/s11999-011-2039-z. Epub 2011 Oct 14.

DOI:10.1007/s11999-011-2039-z
PMID:21997779
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3210260/
Abstract

BACKGROUND

The current standard of care for cervical myopathy is anterior discectomy and fusion (ACDF). Although well tolerated in the short term, this treatment might ultimately result in progressive degeneration of adjacent motion segments. Artificial disc arthroplasty offers the theoretical advantage of preservation of motion at the operative level with consequent stress reduction at adjacent levels.

QUESTIONS/PURPOSES: We compared function, radiographic measures, and incidence of complications at 3-year followup after cervical disc arthroplasty with the Bryan(®) prosthesis and ACDF in patients with cervical myelopathy.

PATIENTS AND METHODS

Eighty-three patients with cervical myelopathy were randomized to undergo arthroplasty with implantation of a Bryan(®) cervical disc prosthesis (n = 41) or ACDF (n = 42). Patients were assessed preoperatively to 3 years postoperatively using the modified Odom's criteria, Japanese Orthopaedic Association scale, SF-36, and Neck Disability Index. ROM, stability, and subsidence of the prostheses were evaluated radiographically.

RESULTS

Patients who received the Bryan(®) prosthesis scored significantly better in three of the four functional assessment methods used (Japanese Orthopaedic Association scale, SF-36, and Neck Disability Index). ROM was retained by the patients in the Bryan(®) group but not in the patients in the ACDF group. Patients in the Bryan(®) group had fewer complications, primarily because dysphagia occurred in only one patient in the Bryan(®) group but in seven patients in the ACDF group. Other complications included pseudarthrosis in three patients in the ACDF group and one patient had spontaneous fusion, one had deep vein thrombosis, and one had heterotopic ossification in the Bryan(®) group.

CONCLUSIONS

Bryan(®) cervical disc arthroplasty appears reliable and effective in the treatment of cervical myelopathy.

LEVEL OF EVIDENCE

Level II, therapeutic study. See the Guidelines for Authors for a complete description of the levels of evidence.

摘要

背景

目前治疗颈肌病的标准方法是前路椎间盘切除融合术(ACDF)。尽管这种治疗方法在短期内效果良好,但最终可能会导致相邻运动节段的进行性退化。人工椎间盘置换术具有保留手术节段运动的理论优势,从而减少相邻节段的压力。

问题/目的:我们比较了颈椎间盘置换术(Bryan(®)人工椎间盘假体)与 ACDF 治疗颈椎脊髓病患者 3 年随访时的功能、影像学测量结果和并发症发生率。

患者和方法

83 例颈椎脊髓病患者随机分为两组,分别接受 Bryan(®)颈椎人工椎间盘假体置换术(n = 41)或 ACDF(n = 42)。患者在术前和术后 3 年分别采用改良 Odom 标准、日本矫形协会量表、SF-36 量表和颈痛残疾指数进行评估。通过影像学评估颈椎假体的活动度、稳定性和下沉情况。

结果

接受 Bryan(®)假体的患者在使用的四种功能评估方法中的三种(日本矫形协会量表、SF-36 量表和颈痛残疾指数)中评分明显更好。Bryan(®)组患者的活动度得到保留,而 ACDF 组患者的活动度则没有保留。Bryan(®)组患者并发症较少,主要是因为 Bryan(®)组只有 1 例患者出现吞咽困难,而 ACDF 组有 7 例患者出现吞咽困难。其他并发症包括 ACDF 组 3 例患者出现假关节,Bryan(®)组 1 例患者出现自发性融合,1 例患者出现深静脉血栓形成,1 例患者出现异位骨化。

结论

Bryan(®)颈椎人工椎间盘置换术治疗颈椎脊髓病可靠有效。

证据等级

Ⅱ级,治疗性研究。完整的证据等级描述请参见作者指南。

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Comparison of BRYAN cervical disc arthroplasty with anterior cervical decompression and fusion: clinical and radiographic results of a randomized, controlled, clinical trial.BRYAN人工颈椎间盘置换术与颈椎前路减压融合术的比较:一项随机对照临床试验的临床和影像学结果
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