A Prospective Randomized FDA-IDE Trial Comparing Cortoss With PMMA for Vertebroplasty A Comparative Effectiveness Research Study With 24-Month Follow-up
A Prospective Randomized FDA-IDE Trial Comparing Cortoss With PMMA for Vertebroplasty A Comparative Effectiveness Research Study With 24-Month Follow-up
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DOI：
10.1097/brs.0b013e31822ba50b
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发表时间：
2012-04-01
期刊：
影响因子：
3
通讯作者：
Persenaire, Maarten
中科院分区：
文献类型：
--
作者：
Bae, Hyun;Hatten, Homer Paul, Jr.;Persenaire, Maarten
研究设计.根据美国食品药品监督管理局研究器械豁免进行的随机、对照、前瞻性（AAOS治疗I级）试验假设一种新型生物活性复合材料非劣于聚甲基丙烯酸甲酯（PMMA）。确定一种新的、不可吸收的生物活性复合材料（Cortoss）与PMMA（椎体压缩性骨折（VCF）的标准治疗方法）相比的安全性和有效性。PMMA椎体成形术是保守治疗无效的VCF广泛采用的治疗方法，可有效、立即缓解疼痛，但该材料因其性能而受到批评。一种专门为椎体成形术设计的新型生物活性复合材料在动物和非随机临床研究中显示出良好的结果，随后在一项随机研究中与PMMA进行了比较。该研究是第一项前瞻性研究，通过24个月的随访，对PMMA与另一种材料进行比较，评估椎体成形术。方法。采用2：1随机化，162例患者使用Cortoss进行椎体成形术，94例患者使用PMMA进行椎体成形术。入选标准为疼痛性眩晕性VCF，100 mm量表上的视觉模拟量表疼痛评分至少为50 mm，并且通过奥斯韦斯特里残疾指数测量的残疾至少为30%。在治疗前、治疗当天和治疗后7个月至24个月的评估包括疼痛、残疾、神经系统状态、不良事件、生活质量、患者满意度、镇痛剂使用和独立审查的X线片。观察到Cortoss相对于PMMA的非劣效性，Cortoss治疗的患者在3个月时疼痛显著缓解（P = 0.0395），在24个月时功能维持或改善更好（P = 0.0299）。两组中严重器械相关不良事件的发生率均为4.3%;无危及生命的不良事件。使用Cortoss或PMMA的椎体成形术可有效、立即和持久地缓解疼痛，并防止进一步丧失功能。两种材料在大多数时间点均表现良好; Cortoss在3个月时的疼痛减轻和24个月时的功能方面表现出更好的结果。
Study Design. Randomized, controlled, prospective (AAOS therapeutic level I) trial conducted under Food and Drug Administration Investigational Device Exemption hypothesized noninferiority of a novel bioactive composite material to polymethylmethacrylate (PMMA).Objective. To determine the safety and efficacy of a new, nonresorbable bioactive composite (Cortoss) compared with PMMA, the standard treatment of vertebral compression fractures (VCFs).Summary of Background Data. Vertebroplasty with PMMA, the widely adopted treatment for VCFs nonresponsive to conservative care, provides effective, immediate pain relief, but the material has received criticism for its properties. A new bioactive composite material designed specifically for vertebroplasty showed promising results in animals and nonrandomized clinical studies and was subsequently compared with PMMA in a randomized study. This study represents the first prospective study evaluating vertebroplasty comparing PMMA with another material with 24-month follow-up.Methods. Using 2: 1 randomization, vertebroplasty was performed with Cortoss on 162 patients and PMMA on 94 patients. Inclusion criteria were painful osteoporotic VCFs with a visual analogue scale pain score of at least 50 mm on a 100-mm scale and at least 30% disability as measured by the Oswestry Disability Index. Evaluations at pretreatment, treatment day, and 7 posttreatment intervals out to 24 months included pain, disability, neurological status, adverse events, quality of life, patient satisfaction, analgesic use, and independently reviewed radiographs.Results. Noninferiority of Cortoss relative to PMMA was observed, with Cortoss-treated patients experiencing significant pain relief at 3 months (P = 0.0395) and better maintenance or improvement in function at 24 months (P = 0.0299). Incidence of serious device-related adverse events was 4.3% in both groups; none were life threatening.Conclusion. Vertebroplasty using either Cortoss or PMMA provides effective, immediate, and lasting pain relief and prevents further loss of function. Both materials performed comparably at most time points; Cortoss demonstrated better results for pain reduction at 3 months and for function at 24 months.