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单节段人工颈椎间盘置换与前路融合术的对照研究

Clinical outcomes of Prestige LP cervical disc replacement: a prospective, controlled, single site trail with 24-month follow-up

摘要目的 观察比较Prestige LP人工颈椎间盘置换术和经前路颈椎间盘切除植骨融合术(anterior cervical discectomy and fusion,ACDF)治疗单节段颈椎间盘突出症的临床效果.方法 2008年1月至2010年3月,87例单节段颈椎间盘突出症患者接受Prestige LP人工颈椎间盘置换手术(置换组,44例)或ACDF手术(融合组,43例).分别在术前,术后1周,术后3、6、12及24个月,对患者进行疼痛视觉模拟评分(visual analogue scale,VAS)、日本矫形外科协会(Japanese Orthopedics Association,JOA)脊髓功能评分和生活质量量表(Short Form-36,SF-36)的评估及影像学评估,同时记录患者并发症及二次手术情况.结果 78例患者获得平均12.4个月(6~24个月)随访.两组患者的颈痛、上肢痛VAS和JOA评分,术后各随访点较术前均有改善(P<0.05),两组间差异无统计学意义(P >0.05).SF-36躯体评分、精神评分术后各点较术前有明显上升(P<0.05);两组间比较,置换组优于融合组(P<0.05).置换组术后手术节段及邻近节段屈伸活动度与术前比较差异无统计学意义(P>0.05),融合组融合成功率为92.1%.置换组中3例患者在3个月时假体有<3 mm的前移,1例患者在术后第3天发生脑脊液漏;融合组中2例患者发生邻椎病并接受二次手术治疗.结论 单节段Prestige LP人工颈椎间盘置换术治疗颈椎间盘突出症,与ACDF手术一样使患者症状缓解明显,且对手术节段及邻近节段活动度影响小.

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abstractsObjective To prospectively compare the effects of Prestige LP cervical disc replacement with those of anterior cervical discectomy and fusion (ACDF) in treatment of cervical disc herniation.Methods From January 2008 to March 2010,a total of 87 patients were enrolled at our site as study investigating ACDF versus Prestige LP cervical disc prosthesis.Forty-four patients received the investigational device (arthroplasty group) and 43 underwent a single-level ACDF (fusion group).Visual analogue scale(VAS) neck/arm pain,Japanese Orthopedics Association (JOA) score,Short Form-36 (SF-36) both physical and mental,flexion-extension range of motion of operative and adjacent segments were evaluated preoperatively and 1 week and 3,6,12,24 months postoperatively.Results A total of 78 patients (89.7%) were followed up for an average 12.4 months (range,6-24).Both groups have favorably demonstrated improved functional outcomes for JOA,VAS scores and SF-36.The improvement in the VAS and JOA scores were equivalent at each follow-up point between the two groups (P>0.05).However,arthroplasty group had statistically significant improvement as assessed by the SF-36 scores compared with the fusion group at some follow-up points (P<0.05).In arthroplasty group,the postoperative range of motion of operative and adjacent segments showed no statistical difference with the preoperative counterpart (P>0.05),and fusion was successful in 92.1% of control patients.Conclusion Prestige LP cervical disc replacement is a feasible alternative to ACDF for patients with persistently symptomatic cervical disc disease and matching the inclusion criteria.

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