Kuslich S D, Danielson G, Dowdle J D, Sherman J, Fredrickson B, Yuan H, Griffith S L
St. Croix Orthopedics, Stillwater, Minnesota 55435, USA.
Spine (Phila Pa 1976). 2000 Oct 15;25(20):2656-62. doi: 10.1097/00007632-200010150-00018.
This was a prospective multicenter clinical trial of a lumbar interbody fusion cage with a minimum of 4 years' follow-up.
To determine whether the early positive clinical results in fusions with lumbar cages, such as the Bagby and Kuslich (BAK) cage, are maintained beyond 2 years.
Threaded cages have been used increasingly for the treatment of symptomatic degenerative intervertebral disc disease. Concerns about the long-term clinical outcomes of this procedure have been posed, particularly regarding bony fusion viability, revision rates, potential adjacent level disease, and late complications.
The study cohort was a 196-patient subset from a prospective investigational device exemption. In addition to early postoperative examinations, these patients were examined biannually with a minimum of 4 years' follow-up. Patient outcome was assessed by a 6-point scale that evaluated pain relief, and functional improvement was determined by changes in activities of daily living. Fusion rates and return to work were determined. Complications and secondary operations were reported and categorized as non-device related or device related.
The patient cohort with 4-year follow-up represented 25.6% of the original study population eligible at that time. Overall, the largest percentage of pain relief and functional improvements occurred by 3 months, and these improvements were maintained at each follow-up. Overall fusion rate was 91.7% and 95. 1% at 2 and 4 years, respectively. In this cohort, 39.5% of patients were working or were able to work within 3 months of surgery. After 4 years, 62.7% of patients were gainfully employed or able to work. The late-occurring complication rate in this cohort was 13.8% (27/196). Complications necessitating a second operation occurred in 8.7% (17/196), whereas reoperations that were deemed device related were performed in 3.1% (6/196).
This study indicates that the early positive benefits of interbody fusion cage procedures are maintained through 4 years with acceptably low morbidity.
这是一项关于腰椎椎间融合器的前瞻性多中心临床试验，随访时间至少为4年。
确定腰椎融合器（如Bagby和Kuslich（BAK）融合器）融合早期的积极临床效果在2年以上是否仍能维持。
螺纹融合器越来越多地用于治疗有症状的退行性椎间盘疾病。人们对该手术的长期临床结果提出了担忧，特别是关于骨融合的可行性、翻修率、潜在的相邻节段疾病和晚期并发症。
研究队列是来自一项前瞻性研究器械豁免试验的196例患者亚组。除了术后早期检查外，这些患者每半年接受一次检查，随访时间至少为4年。通过一个评估疼痛缓解的6分制量表评估患者预后，并通过日常生活活动的变化确定功能改善情况。确定融合率和重返工作岗位情况。报告并发症和二次手术情况，并分为与器械无关或与器械有关两类。
有4年随访的患者队列占当时符合条件的原始研究人群的25.6%。总体而言，最大比例的疼痛缓解和功能改善在3个月时出现，并且在每次随访时都得以维持。2年和4年时的总体融合率分别为91.7%和95.1%。在该队列中，39.5%的患者在手术后3个月内恢复工作或能够工作。4年后，62.7%的患者有收益性工作或能够工作。该队列中的晚期并发症发生率为13.8%（27/196）。需要二次手术的并发症发生率为8.7%（17/196），而被认为与器械有关的再次手术发生率为3.1%（6/196）。
本研究表明，椎间融合器手术早期的积极益处可持续4年，发病率低至可接受水平。
