Phillips Frank M, Allen Todd R, Regan John J, Albert Todd J, Cappuccino Andrew, Devine John G, Ahrens Jeanette E, Hipp John A, McAfee Paul C
Rush University Medical Center, Chicago, IL 60612, USA.
Spine (Phila Pa 1976). 2009 Mar 15;34(6):556-65. doi: 10.1097/BRS.0b013e31819b061c.
Prospective 6-center study. OBJECTIVE.: To evaluate outcomes of cervical disc replacement performed adjacent to a prior cervical fusion.
The use of disc replacement adjacent to a prior anterior cervical decompression and fusion (ACDF) is an attractive reconstructive option, obviating the need for a multilevel fusion. This study reports outcomes from patients with and without previous ACDF receiving the porous coated motion (PCM) artificial cervical disc in a United States Federal Drug Administration Investigational Device Exemption trials.
Patients between ages of 18 and 65 with single-level cervical radiculopathy and/or myelopathy, unresponsive to at least 6 weeks of nonsurgical therapy, or experiencing progressive neurologic symptoms were enrolled. Clinical outcomes are compared for patients receiving a PCM disc at a level adjacent to a prior ACDF ("adjacent") and those without having previously had fusion ("primary").
126 PCM patients were primary (mean age: 44.4 years.) and 26 patients had previous "adjacent level" fusion surgery (mean age: 46.4 years). Surgery time was similar in both groups (96 minutes and 98 minutes, respectively; P = 0.761), and mean blood loss was 76 mL and 66 mL in the 2 groups, respectively (P = 0.491). Clinical outcomes using Neck Disability Index and Visual Analog Scores neck and arm scores showed significant improvement after surgery and were similar between groups at all time points. Revision surgery occurred in 2 of 126 primary patients, and in 2 of 26 patients in the adjacent-to-fusion group.
Although the level adjacent to a prior cervical fusion is subject to increased biomechanical forces, potentially leading to a higher risk of failure, the PCM disc was well tolerated in the short term. The early clinical results of disc replacement adjacent to a prior fusion are good and comparable to the outcomes after primary disc replacement surgery. However, in view of the small study population and short-term follow-up, continued study is mandatory.
前瞻性6中心研究。目的：评估在先前颈椎融合术相邻节段进行颈椎间盘置换的结果。
在先前颈椎前路减压融合术（ACDF）相邻节段使用椎间盘置换是一种有吸引力的重建选择，无需进行多节段融合。本研究报告了在美国食品药品监督管理局器械临床试验豁免试验中，接受多孔涂层活动（PCM）人工颈椎间盘的既往有或无ACDF患者的结果。
纳入年龄在18至65岁之间、患有单节段颈椎神经根病和/或脊髓病、对至少6周的非手术治疗无反应或出现进行性神经症状的患者。比较在先前ACDF相邻节段接受PCM椎间盘的患者（“相邻节段”）和先前未进行融合的患者（“初次置换”）的临床结果。
126例接受PCM置换的患者为初次置换（平均年龄：44.4岁），26例患者先前接受过“相邻节段”融合手术（平均年龄：46.4岁）。两组手术时间相似（分别为96分钟和98分钟；P = 0.761），两组平均失血量分别为76 mL和66 mL（P = 0.491）。使用颈部功能障碍指数和视觉模拟评分的颈部和手臂评分显示，术后临床结果有显著改善，且在所有时间点两组之间相似。126例初次置换患者中有2例进行了翻修手术，融合相邻节段组的26例患者中有2例进行了翻修手术。
尽管先前颈椎融合术相邻节段承受的生物力学力增加，可能导致更高的失败风险，但PCM椎间盘在短期内耐受性良好。先前融合相邻节段椎间盘置换的早期临床结果良好，与初次椎间盘置换手术后的结果相当。然而，鉴于研究人群规模小且随访时间短，必须继续进行研究。
