McAfee Paul C, Geisler Fred H, Saiedy Samer S, Moore Sandra V, Regan John J, Guyer Richard D, Blumenthal Scott L, Fedder Ira L, Tortolani P Justin, Cunningham Bryan
Spine and Scoliosis Center, St. Joseph's Hospital, Baltimore, MD, USA.
Spine (Phila Pa 1976). 2006 May 15;31(11):1217-26. doi: 10.1097/01.brs.0000217689.08487.a8.
A prospective, randomized, multicenter, FDA-regulated Investigational Device Exemption clinical trial.
To analyze the incidence of, and reasons for, reoperation in all patients (treatment and control) enrolled in the IDE study.
This is the first report of the incidence and nature of reoperations following lumbar TDR as part of a controlled, prospective, multicenter trial.
A total of 688 patients meeting the inclusion and exclusion criteria were enrolled in one of three arms of the study at 14 centers across the United States. This cohort includes 71 nonrandomized cases, 205 randomized cases, and 313 continued access cases, all receiving the CHARITE Artificial Disc, as well as 99 randomized cases in the control group (ALIF with threaded fusion cages and autograft). A detailed analysis was performed of clinical chart notes, operative notes, and adverse event reports for all patients requiring reoperation following their index surgery.
Of the 589 patients with TDR, 52 (8.8%) required reoperation. Of the 99 patients with lumbar fusion, 10 (10.1%) required reoperation, and an additional 2 required surgery for adjacent level disease (P = 0.7401). There were 24 TDR patients who underwent a repeated anterior retroperitoneal approach, with 22 (91.7%) having had a successful removal of the prosthesis. Seven of the 24 TDR prostheses requiring removal were revised to another CHARITE Artificial Disc. The mean time to reoperation in all patients was 9.7 months. A total of 29 patients (4.9%) in the TDR group required posterior instrumentation and fusion as did 10 (10.1%) in the control group (P = 0.0562). At 2 years or more follow-up, 93.9%(553/589 = 93.9%) of patients receiving TDR with the CHARITE Artificial Disc had a successfully functioning prosthesis with a mean of over 7 degrees of flexion-extension mobility.
Lumbar TDR with the CHARITE Artificial Disc did not preclude any further procedures at the index level during primary insertion, with nearly one third being revisable to a new motion-preserving prosthesis and just over two thirds being successfully converted to ALIF and/ or posterior pedicle screw arthrodesis, the original alternative procedure.
一项前瞻性、随机、多中心、由美国食品药品监督管理局（FDA）监管的研究性器械豁免临床试验。
分析参与该研究性器械豁免（IDE）研究的所有患者（治疗组和对照组）再次手术的发生率及原因。
这是作为一项对照、前瞻性、多中心试验一部分的腰椎全椎间盘置换术（TDR）后再次手术发生率及性质的首份报告。
共有688例符合纳入和排除标准的患者在美国14个中心参与了该研究的三个分组之一。该队列包括71例非随机病例、205例随机病例和313例持续入组病例，所有这些患者均接受CHARITE人工椎间盘，以及对照组中的99例随机病例（前路腰椎椎间融合术，使用螺纹融合器和自体骨移植）。对所有初次手术后需要再次手术的患者的临床病历记录、手术记录和不良事件报告进行了详细分析。
在589例接受TDR的患者中，52例（8.8%）需要再次手术。在99例接受腰椎融合术的患者中，10例（10.1%）需要再次手术，另外2例因相邻节段疾病需要手术（P = 0.7401）。有24例TDR患者接受了重复的前路腹膜后入路，其中22例（91.7%）成功取出了假体。24例需要取出的TDR假体中有7例被翻修为另一个CHARITE人工椎间盘。所有患者再次手术的平均时间为9.7个月。TDR组共有29例患者（4.
