CERAMENT 治疗骨折缺损（CERTiFY）：一项前瞻性、多中心、随机研究的方案，旨在研究 CERAMENT™ 骨空洞填充剂在胫骨平台骨折中的应用。
CERAMENT treatment of fracture defects (CERTiFy): protocol for a prospective, multicenter, randomized study investigating the use of CERAMENT™ BONE VOID FILLER in tibial plateau fractures.
机构信息
BiomaTiCS Group, Center for Orthopedics and Trauma Surgery, University Medical Center, Langenbeckstr, 1, Mainz D-55131, Germany.
出版信息
Trials. 2014 Mar 8;15:75. doi: 10.1186/1745-6215-15-75.
BACKGROUND
Bone graft substitutes are widely used for reconstruction of posttraumatic bone defects. However, their clinical significance in comparison to autologous bone grafting, the gold-standard in reconstruction of larger bone defects, still remains under debate. This prospective, randomized, controlled clinical study investigates the differences in pain, quality of life, and cost of care in the treatment of tibia plateau fractures-associated bone defects using either autologous bone grafting or bioresorbable hydroxyapatite/calcium sulphate cement (CERAMENT™|BONE VOID FILLER (CBVF)).
METHODS/DESIGN: CERTiFy (CERament™ Treatment of Fracture defects) is a prospective, multicenter, controlled, randomized trial. We plan to enroll 136 patients with fresh traumatic depression fractures of the proximal tibia (types AO 41-B2 and AO 41-B3) in 13 participating centers in Germany. Patients will be randomized to receive either autologous iliac crest bone graft or CBVF after reduction and osteosynthesis of the fracture to reconstruct the subchondral bone defect and prevent the subsidence of the articular surface. The primary outcome is the SF-12 Physical Component Summary at week 26. The co-primary endpoint is the pain level 26 weeks after surgery measured by a visual analog scale. The SF-12 Mental Component Summary after 26 weeks and costs of care will serve as key secondary endpoints. The study is designed to show non-inferiority of the CBVF treatment to the autologous iliac crest bone graft with respect to the physical component of quality of life. The pain level at 26 weeks after surgery is expected to be lower in the CERAMENT bone void filler treatment group.
DISCUSSION
CERTiFy is the first randomized multicenter clinical trial designed to compare quality of life, pain, and cost of care in the use of the CBVF and the autologous iliac crest bone graft in the treatment of tibia plateau fractures. The results are expected to influence future treatment recommendations.
TRIAL REGISTRATION NUMBER
ClinicalTrials.gov: NCT01828905.
背景
骨移植替代物广泛用于外伤性骨缺损的重建。然而，与自体骨移植相比，其在重建较大骨缺损方面的临床意义仍存在争议，自体骨移植是重建的金标准。本前瞻性、随机、对照临床试验研究了使用自体骨移植或可吸收羟基磷灰石/硫酸钙水泥（CERAMENT™|骨void 填充剂（CBVF））治疗胫骨平台骨折相关骨缺损时疼痛、生活质量和治疗费用的差异。
方法/设计：CERtify（CERament™治疗骨折缺陷）是一项前瞻性、多中心、对照、随机试验。我们计划在德国 13 个参与中心招募 136 例新鲜创伤性胫骨近端压缩骨折患者（AO 41-B2 和 AO 41-B3 型）。患者将随机接受自体髂嵴骨移植或 CBVF，以重建软骨下骨缺损并防止关节面下沉。主要结局是第 26 周时 SF-12 生理成分综合评分。主要次要结局是术后 26 周视觉模拟评分（VAS）测量的疼痛水平。SF-12 心理成分综合评分和治疗费用将作为关键次要结局。该研究旨在证明 CBVF 治疗在生活质量生理成分方面不劣于自体髂嵴骨移植。术后 26 周时，CBVF 治疗组的疼痛水平预计较低。
讨论
CERtify 是第一项旨在比较 CBVF 和自体髂嵴骨移植治疗胫骨平台骨折时使用生活质量、疼痛和治疗费用的随机多中心临床试验。预计结果将影响未来的治疗建议。
试验注册
ClinicalTrials.gov：NCT01828905。
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