Department of Orthopaedic and Trauma Surgery, University of Cologne, Kerpener Strasse 62, 50924 Cologne, Germany.
BMC Musculoskelet Disord. 2011 Oct 18;12:239. doi: 10.1186/1471-2474-12-239.
Fusion of lumbar spine segments is a well-established therapy for many pathologies. The procedure changes the biomechanics of the spine. Initial clinical benefits may be outweighed by ensuing damage to the adjacent segments. Various surgical devices and techniques have been developed to prevent this deterioration. "Topping off" systems combine rigid fusion with a flexible pedicle screw system to prevent adjacent segment disease (ASD). To date, there is no convincing evidence that these devices provide any patient benefits.
METHODS/DESIGN: The study is designed as a randomized, therapy-controlled trial in a clinical care setting at a university hospital. Patients presenting to the outpatient clinic with degenerative disc disease or spondylolisthesis will be assessed against study inclusion and exclusion criteria. After randomization, the control group will undergo conventional fusion. The intervention group will undergo fusion with a supplemental flexible pedicle screw system to protect the adjacent segment ("topping off").Follow-up examination will take place immediately after treatment during hospital stay, after 6 weeks, and then after 6, 12, 24 and 36 months. Subsequently, ongoing assessments will be performed annually.Outcome measurements will include quality of life and pain assessments using questionnaires (SF-36™, ODI, COMI). In addition, clinical and radiologic ASD, work-related disability, and duration of work disability will be assessed. Inpatient and 6-month mortality, surgery-related data (e.g., intraoperative complications, blood loss, length of incision, surgical duration), postoperative complications, adverse events, and serious adverse events will be documented and monitored throughout the study. Cost-effectiveness analysis will also be provided.
New hybrid systems might improve the outcome of lumbar spine fusion. To date, there is no convincing published data on effectiveness or safety of these topping off systems. High quality data is required to evaluate the benefits and drawbacks of topping off devices. If only because these devices are quite expensive compared to conventional fusion implants, nonessential use should be avoided. In fact, these high costs necessitate efforts by health care providers to evaluate the effects of these implants. Randomized clinical trials are highly recommended to evaluate the benefits or harm to the patient.
ClinicalTrials.gov: NCT01224379.
融合腰椎节段是治疗许多疾病的成熟疗法。该手术改变了脊柱的生物力学。最初的临床获益可能会因后续对相邻节段的损害而被抵消。已经开发出各种手术设备和技术来防止这种恶化。“加帽”系统将刚性融合与灵活的椎弓根螺钉系统相结合，以预防相邻节段疾病（ASD）。迄今为止，没有令人信服的证据表明这些设备为患者带来任何益处。
方法/设计：该研究设计为在大学附属医院的临床护理环境中进行的随机、治疗对照试验。在门诊就诊的退行性椎间盘疾病或脊椎滑脱患者将根据研究纳入和排除标准进行评估。随机分组后，对照组将接受常规融合。干预组将采用补充灵活的椎弓根螺钉系统进行融合，以保护相邻节段（“加帽”）。治疗后立即在住院期间、6 周后以及 6、12、24 和 36 个月后进行随访检查。随后，将每年进行持续评估。结果测量将包括使用问卷（SF-36™、ODI、COMI）进行生活质量和疼痛评估。此外，还将评估临床和影像学 ASD、与工作相关的残疾以及工作残疾持续时间。将记录并监测整个研究期间的住院和 6 个月死亡率、手术相关数据（例如，术中并发症、失血量、切口长度、手术时间）、术后并发症、不良事件和严重不良事件。还将提供成本效益分析。
新型混合系统可能会改善腰椎融合的结果。迄今为止，尚无关于这些加帽系统有效性或安全性的令人信服的已发表数据。需要高质量的数据来评估加帽装置的优缺点。由于与传统融合植入物相比，这些设备相当昂贵，因此应避免不必要的使用。实际上，这些高成本要求医疗保健提供者努力评估这些植入物的效果。强烈建议进行随机临床试验，以评估对患者的益处或危害。
ClinicalTrials.gov：NCT01224379。
