单节段人工颈椎间盘置换与前路融合术的对照研究

 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(an terior 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(P0.05)。SF-36躯体评分、精神 评分术后各点较术前有明显上升(P0.05), 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。

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

Objective 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 and1 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 (P0.05), 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.