Hall B B, Asher M A, Zang R H, Quinn L M
University of Texas Health Science Center At San Antonio, USA.
Spine (Phila Pa 1976). 1996 Apr 15;21(8):982-94. doi: 10.1097/00007632-199604150-00014.
This is a prospective study designed in consultation with and approved by the Food and Drug Administration with the purpose of determining the safety and efficacy of the Isola Spinal Implant System for the surgical treatment of patients with degenerative disc disease.
To report the results of the degenerative disc disease group from the Isola Investigational Device Exemption study, which was done to determine whether the Isola Spinal Implant System is a safe and effective treatment.
The safety and efficacy of transpedicular instrumentation as an adjunct in achieving lumbar spine fusion are still debated.
Hospital Investigational Review Board approval of the study protocol was obtained at the 10 participating centers. One hundred twenty patients (49 men and 71 women; average age, 54 years [range, 25-83 years]) were enrolled. Clinical and radiographic follow-up evaluation was done using protocols established prospectively.
Of the 120 patients, 12 (10%) had device-related problems. There were two operative and four device related complications after surgery. Six other patients had their implants removed either for local pain (two) or for looseness or breakage (four). Of 118 patients eligible for follow-up evaluation at 24 months, 107 (91%) were available for study. Fusion was achieved in 97 (91%) patients. Average combined function and pain scores improved by 2.6 points (P < 0.0001). Clinical success, as measured by combining function and pain scores, was achieved in 65% of the patients by the most stringent criteria and 73% by less stringent criteria. Clinical success was significantly higher in patients who had not had previous surgery than in those who had, 77% versus 57% (P = 0.04).
The present study suggests that the Isola Spinal Implant System can be safely used, is an effective adjunct in the achievement of fusion, and yields an acceptable number of successful clinical outcomes, especially when considering the preponderance of previously operated patients included in this group.
这是一项经食品药品监督管理局咨询并批准的前瞻性研究，目的是确定Isola脊柱植入系统用于退行性椎间盘疾病患者手术治疗的安全性和有效性。
报告Isola研究性器械豁免研究中退行性椎间盘疾病组的结果，该研究旨在确定Isola脊柱植入系统是否为一种安全有效的治疗方法。
经椎弓根器械作为腰椎融合辅助手段的安全性和有效性仍存在争议。
在10个参与中心获得了医院研究审查委员会对研究方案的批准。共纳入120例患者（49例男性和71例女性；平均年龄54岁[范围25 - 83岁]）。采用前瞻性制定的方案进行临床和影像学随访评估。
120例患者中，12例（10%）出现与器械相关的问题。术后有2例手术相关和4例器械相关并发症。另外6例患者因局部疼痛（2例）或植入物松动或断裂（4例）而取出植入物。在118例符合24个月随访评估条件的患者中，107例（91%）可供研究。97例（91%）患者实现了融合。功能和疼痛综合评分平均提高了2.6分（P < 0.0001）。按照最严格标准，通过综合功能和疼痛评分衡量的临床成功率在65%的患者中实现，按照较宽松标准则为73%。未接受过先前手术的患者临床成功率显著高于接受过先前手术的患者，分别为77%和57%（P = 0.04）。
本研究表明，Isola脊柱植入系统可以安全使用，是实现融合的有效辅助手段，并且能产生可接受数量的成功临床结果，尤其是考虑到该组中先前接受过手术的患者占多数的情况。
