Bryan颈椎人工椎间盘置换术的长期疗效观察

目的 评估Bryan颈椎人工椎间盘置换术的长期疗效。方法 对2004年12月至2008年8月于我院行Bryan颈椎人工椎间盘置换术的20例病人进行回顾性分析,男15例,女5例,平均年龄为（43.85±3.70）岁,其中单节段9例,双节段11例,C_3/4 2例、C_4/5 9例、C_5/6 15例、C_6/7 5例。①收集并比较其术前、术后1周、术后2年及末次随访的改良日本骨科协会（modified Japanese Orthopaedic Association, mJOA）评估治疗分数、疼痛视觉模拟量表（visual analogue scale, VAS）评分、颈椎功能障碍指数（neck disability index, NDI）以及Odom''s分级。②通过其术前、术后早期及末次随访时的X线侧位片及颈椎过屈过伸位片,评估其颈椎曲度、颈椎活动度（ROM）。③MRI T2加权像上根据Miyazaki分级标准评估Bryan人工椎间盘置换术后邻近节段的退变情况。④通过X线片及CT片根据McAfee标准评价异位骨化的发生情况。结果 ①术前及末次随访时的mJOA评分分别为（13.30±2.83）分、（15.25±2.07）分,VAS评分分别为（4.10±3.81）分、（1.55±1.53）分,NDI分别为（11.45±9.52）分、（6.00±4.78）分,所有评价指标末次随访时较术前均有显著改善,差异均有统计学意义（P均＜0.05）。末次随访时Odom''s分级为优8例,良8例,可2例,差2例。②脊柱功能单位（FSU）曲度及C₂~C₇曲度：术前分别为2.33°±4.08°、18.78°±6.68°,术后早期为4.12°±6.43°、20.00°±9.98°,末次随访时分别为3.21°±6.56°、15.61°±6.73°。FSU ROM及C₂~C₇ ROM：术前分别为9.15°±2.80°、47.28°±9.75°,术后早期为9.27°±3.83°、40.81°±14.66°,末次随访分别为9.37°±3.97°、42.03°±10.97°。3个时间点的FSU曲度及FSU ROM比较,差异均无统计学意义（P均＞0.05）,但C₂~C_{7 ROM术后较术前明显减少,与邻近节段ROM变化趋势一致。末次随访时,43个邻近节段中46.5%发生邻近节段退变（adjacent segment degeneration, ASD）,以C5/6最为常见,但均无临床表现;末次随访时31个手术节段中有23例（74.2%）发生异位骨化,其中严重异位骨化（Ⅲ、Ⅳ级）发生率为22.6%,C5/6最为常见。结论 Bryan颈椎人工椎间盘置换术治疗颈椎退变性疾病可以取得持久稳定的临床效果,尽管异位骨化发生率较高,但大部分保留手术节段活动,同时邻近节段仍可见退变,但均无临床症状。}     

Bryan人工颈椎间盘置换对颈椎功能影响的临床分析

目的 探讨Bryan人工颈椎间盘置换手术对颈椎功能的影响.方法 对2003年12月至2007年8月施行的164例患者200个椎间盘的人工颈椎间盘置换手术进行回顾性分析.164例患者中,男性102例,女性62例,年龄25～70岁,平均47岁;单间隙置换132例,双间隙置换28例,三间隙置换4例.均采用Bryan人工颈椎间盘假体.手术严格按照Bryan人工颈椎间盘假体植入的标准操作程序进行.术后颈托外固定2周.结果 随访时间2～44个月,平均26个月.JOA评分改善率56%.椎间活动度:矢状位术前平均活动度14.4°,术后1周5.7°,末次随访时平均14.7°,与手术前相比差异无统计学意义.邻近间隙矢状位术前平均活动度10.9°,术后1周5.5°,末次随访时平均8.2°,主要是由上邻接间隙的活动度没有达到术前水平所致.患者满意度94%.1例患者术后6个月假体松动,以后稳定;1例患者术后7个月假体发生1 mm下沉,以后稳定;3例后方融合.无前方融合、食管损伤、喉返神经损伤以及再手术病例.手术操作单间隙平均90 min,双间隙平均130 min.结论 人工颈椎间盘置换手术临床疗效良好.     

Bryan人工颈椎间盘置换术治疗颈椎病的中期疗效观察

摘要：目的观察Bryan人工颈椎间盘置换术治疗颈椎病的中期疗效。方法2005年11月至2010年5月对16例颈椎病患者行Bryan人工颈椎间盘置换术。统计并分析患者术前、术后及末次随访时的JOA评分、置换节段活动度,观察术后及末次随访时假体松动、移位、异位骨化等并发症。结果16例患者均获得随访,随访时间为12—53个月,平均24．1个月,JOA评分由术前平均（10．4±1．9）分增至术后平均（14．4±1．9）分以及末次随访平均（16．1±0．7）分,术前与术后（t=-12．215,P=0．000）、术后与末次随访（t=-4．273,P=0．001）均有显著性差异。12例患者随访时行颈椎屈伸位x线片检查,随访时间13—53月,平均24．2月,测量屈伸位X线片计算置换节段颈椎屈伸活动度（rangeofmotion,ROM）,术前平均7．1°±2．6°、术后平均6．9°±1．9°、末次随访平均6．5°±1．8°,术前与术后（t=0．700,P=0．395）、术后与末次随访（t=2．132,P=0．054）均无统计学差异。无一例发生异位骨化;1例随访时出现假体周围骨吸收。结论Bryan人工颈椎间盘置换术治疗颈椎病的中期疗效满意,但仍需长时间随访以评估其远期疗效。     

Bryan cervical disc prosthesis: 12-month clinical outcome

A prospective observational clinical study was carried out to determine whether Bryan disc replacement surgery is a suitable alternative to arthrodesis for cervical disc disease.     

Bryan人工椎间盘置换术对颈椎曲度影响的研究

目的观察不同手术时期Bryan人工椎间盘置换术后置换节段脊柱功能单位（functional spine unit,FSU）曲度变化情况。方法随访2003年12月～2007年12月接受单节段Bryan人工椎间盘置换术的患者,在侧位X线片上测量FSU角度变化。结果 60例患者获得随访,随访3～69个月,平均32个月,手术节段包括C3/C4节段2例,C4/C5节段14例,C5/C6节段41例,C6/C7节段3例。术前FSU平均曲度为0.3°,末次随访时为-0.5°（P〈0.05）。根据手术日期将全部病例分成早期（2003～2004年）、中期（2005年）和后期（2006～2007年）3组,统计分析发现早期病例随访时FSU后凸平均增加1.6°,后期病例FSU后凸平均增加仅0.1°,2组的FSU角度变化差异有统计学意义（P〈0.05）。结论 Bryan人工颈椎椎间盘置换术术后FSU后凸主要发生在早期病例,通过经验的积累和手术技术的改进可以避免术后FSU后凸。     

Uncovertebral hypertrophy is a significant risk factor for the occurrence of heterotopic ossification after cervical disc replacement: survivorship analysis of Bryan disc for single-level cervical arthroplasty

Objectives  

The purpose of this study is to investigate the incidence of heterotopic ossification (HO) in the Bryan cervical arthroplasty group and to identify associations between preoperative factors and the development of HO.     

Bryan人工颈椎间盘置换术治疗颈椎病早中期疗效观察

[目的]探讨Bryan人工颈椎间盘置换术缓解颈椎病神经症状和体征,提高患者的生活质量,并保持颈椎稳定和节段活动.[方法]对19例23个椎间盘的人工颈椎间盘置换术进行了随访.随诊时间8～76个月,平均29个月.其中脊髓型颈椎病15例,其他4例.男12例,女7例;年龄35～52岁,平均40.5岁.单节段置换16例,双节段2例,3节段1例.[结果]术中或术后没有神经和血管损伤的并发症.JOA评分从平均8.6分增加到15.8分.没有假体下沉和明显偏移.置换节段稳定并部分恢复了颈椎正常的活动范围,前屈和后伸活动范围是4.68°(3.6°～6.1°);左右侧屈的活动范围是3.51°(2.5°～4.6°)、3.42°(2.6°～4.3°).CT和MRI随访表明2/23节段的假体偏移＜1.5 mm.颈椎的生理弧度没有明显的丢失.置换节段假体周围没有骨化.[结论]19例人工颈椎间盘置换术取得了满意的近期疗效.与颈椎前路椎间盘摘除植骨融合术最大的不同点是患者恢复快,没有颈椎活动受限的缺陷.但至少需要5年的长期随访来评价假体的功能和对邻近节段的影响.     

Bryan颈椎间盘假体置换治疗硬膜外型颈椎间盘突出症

目的探讨Bryan人工颈椎间盘置换应用于硬膜外型颈椎间盘突出症的手术技巧并评价其近期临床疗效。方法2005年2月~2005年12月,对5例硬膜外型颈椎间盘突出症患者实施前路减压 Bryan颈椎间盘假体置换术。术前摄颈椎正、侧位和动力位X线片,颈椎CT、MRI并进行颈椎病JOA评分。术后1周复查颈椎X线片以了解假体位置及其活动功能情况;复查颈椎MRI,了解颈段脊髓减压情况。本组病例均获随访3~13个月(平均7个月),分别于术后6周、3个月重新进行JOA评分。结果本组患者均完成单节段椎间盘置换,术后无神经、血管损伤等并发症发生;颈椎MRI示所有患者颈脊髓减压彻底,术后临床症状均显著改善;术后6周及3个月的JOA评分较术前有明显提高。至最后一次随访复查,手术节段活动度无明显丢失,假体均无偏移、下沉等。结论对硬膜外型颈椎间盘突出症行Bryan颈椎间盘假体置换术时,在满足假体骨床的前提下,仍可获得充分的颈脊髓减压。     

人工颈椎椎间盘置换治疗单节段颈椎病的前瞻性随机对照研究

目的前瞻性对比Bryan人工颈椎椎间盘置换和颈前路椎间盘切除融合术（anterior cervical discectomy andfusion,ACDF）对颈椎病治疗的临床结果。方法 2006年8月～2009年2月连续治疗的59名单间隙脊髓型或神经根型颈椎病患者,随机分为2组：Bryan组和ACDF组。比较2组手术时间、手术出血量、住院时间等临床数据,同时分别于术后6周、3个月6、个月1、2个月2、4个月应用疼痛视觉模拟量表（visual analog scale,VAS）、上肢疼痛VAS、颈椎功能障碍指数（neck disability index,NDI）、影像学测量等方法进行2组的评估。结果 2组在手术时间、手术出血量及住院时间的差异无统计学意义（P〉0.05）。颈痛VAS、颈部NDI术后6周、3个月2组的差异有统计学意义（P〈0.05）,其余各随访时间段2组差异均无统计学意义（P〉0.05）,但与术前相比差异有统计学意义（P〈0.05）。影像学测量手术节段及整个颈椎的过伸过曲位角度变化：Bryan组置换节段正常活动范围存在,ACDF组置换节段无角度变化;整个颈椎的屈伸范围Bryan组在各个时间段与术前相比差异无统计学意义（P〉0.05）,而ACDF组在术后6周3、个月与术前相比差异有统计学数（P〈0.05）6,个月逐渐恢复正常。结论经过中期的临床随访,Bryan人工颈椎椎间盘置换保持了病变节段正常的屈伸活动范围,可以取得与ACDF相似的临床效果,而且手术后短期内治疗效果优于ACDF。     

The Bryan cervical disc prosthesis. Preliminary clinical experience with nine implants

PURPOSE: After an anterior cervical discectomy, immobility at the fused level may increase stress on adjacent disc spaces and causes disc degeneration in 92% of the cases with clinical manifestations in 25.6% of the patients within 10 years. The cervical disk prosthesis may help to prevent this problem. The Bryan prosthesis (Medtronic Sofamor Danek) is currently available in France after a European pilot study. METHODS: Since January 2002, 8 patients (9 implants) (mean age: 35 years) were operated on with a prosthesis implantation for disc degeneration after an adjacent previous interbody fusion in 2 patients and for disc herniation or spondylosis in 6 patients. The prosthesis were implanted at the C4-C5 level (one patient), C5-C6 (four patients), and C6-C7 (four patients). Post-operative radiological evaluations with dynamic X-rays and clinical status (Odom questionnaire) were analyzed. RESULTS: Surgical procedures, which were longer than the classical technique, were uneventful. Radicular pain resolved after surgery with excellent results with the Odom's score. With a mean follow-up of 12 months, the prosthesis mobility was 8.9 degrees . But one fusion of an implant was encountered 6 months after implantation. CONCLUSIONS: The general follow-up for the Bryan(R) cervical disc prosthesis implantation is still too short (2 years) for a definitive evaluation. If clinical results on pain are as good as expected, long-term mobility of the prosthesis has to be checked, as it is the main advantage over classical anterior cervical discectomy with fusion. Patient selection has to be considered.     

人工颈椎间盘假体置换治疗颈椎病的早期临床研究

目的探讨初期应用人工颈椎间盘假体治疗颈椎病的疗效。方法应用Bryan人工椎间盘假体置换治疗脊髓型颈椎病和神经根型颈椎病患者18例（22个节断）,术前、术后进行JOA评分比较评价早期治疗效果;术后摄置换节段前屈后伸位,左右侧屈位X线片,观察稳定性和植入节段的活动度。结果随访16～36个月,平均20个月。无伤口感染及假体脱位病例,患者JOA评分由术前平均9．0（7～11）分上升至术后平均15．0（13～17）分,术后3个月置换节段前屈后伸活动范围平均4．8°（4．1°～5．5°）,左右侧屈活动范围分别为3．7°（3．4°～4．0°）和3．6°（3．3°～3．9°）。X线片显示颈椎稳定性好,运动功能无明显丢失。结论应用人工颈椎间盘假体置换治疗颈椎间盘疾病早期效果良好。     

The Bryan cervical disc system

In May 2002, an Investigational Device Exemption (IDE) was granted by the US Food and Drug Administration (FDA) for clinical evaluation of the Bryan Cervical Disc System. The trial was designed to demonstrate equivalence with anterior discectomy and interbody fusion with plate fixation. Trial enrollment of over 500 patients was completed in 2004, and 2-year follow-up data are currently being collected and analyzed in preparation for submission to the FDA. This article describes the Bryan prosthesis, reviews several preclinical and clinical studies, and reports on the IDE study.     

Complications of Bryan cervical disc replacement

The primary goals of cervical disc replacement are to avoid fusion in the affected segment, maintain the mobility and function of the involved cervical segments, allow patients to quickly return to routine activities and reduce or eliminate adjacent‐segment disease. A large number of patients have already undergone, and more and more patients will in the future undergo, cervical disc replacement. The cervical device which best preserves movement, and has therefore been the device of choice, has been the Bryan cervical disc. Although a safe surgical technique has been demonstrated and favorable results of using the Bryan disc reported, some complications have also accompanied this arthroplasty. Complications of Bryan cervical disc replacement include those related to the operative approach and decompression process, loosening and failure of the device, postoperative kyphosis, heterotopic ossification, and loss of movement due to spontaneous fusion. In order to avoid these complications, strict patient selection criteria and a meticulous knowledge of anatomy are necessary.