Orthopedic Oncology Clinic, National Cancer Center, Goyang, Korea.
Clin Orthop Surg. 2011 Sep;3(3):191-201. doi: 10.4055/cios.2011.3.3.191. Epub 2011 Aug 19.
Injectable calcium sulfate is a clinically proven osteoconductive biomaterial, and it is an injectable, resorbable and semi-structural bone graft material. The purpose of this study was to validate the clinical outcomes of injectable calcium sulfate (ICS) grafts as compared with those of a demineralized bone matrix (DBM)-based graft for filling in contained bony defects created by tumor surgery.
Fifty-six patients (41 males and 15 females) with various bone tumors and who were surgically treated between September 2003 and October 2007 were included for this study. The patients were randomly allocated into two groups, and either an ICS graft (28 patients) or a DBM-based graft (28 patients) was implanted into each contained defect that was developed by the surgery. The radiographic outcomes were compared between the two groups and various clinical factors were included for the statistical analysis.
When one case with early postoperative pathologic fracture in the DBM group was excluded, the overall success rates of the ICS and DBM grafting were 85.7% (24/28) and 88.9% (24/27) (p > 0.05), respectively. The average time to complete healing was 17.3 weeks in the ICS group and 14.9 weeks in the DBM group (p > 0.05). Additionally, the ICS was completely resorbed within 3 months, except for one case.
Although the rate of resorption of ICS is a concern, the injectable calcium sulfate appears to be a comparable bone graft substitute for a DBM-based graft, with a lower cost, for the treatment of the bone defects created during surgery for various bone tumors.
注射用硫酸钙是一种经过临床验证的骨诱导生物材料，是一种可注射、可吸收、半结构性的骨移植材料。本研究的目的是验证注射用硫酸钙（ICS）移植体与脱钙骨基质（DBM）基移植体在填充肿瘤手术后形成的含骨缺损方面的临床疗效。
本研究纳入了 2003 年 9 月至 2007 年 10 月期间接受手术治疗的 56 例（男 41 例，女 15 例）各种骨肿瘤患者。患者被随机分为两组，每组 28 例患者分别植入 ICS 移植体或 DBM 基移植体。对两组患者的影像学结果进行比较，并对各种临床因素进行统计学分析。
在排除 DBM 组 1 例术后早期病理骨折后，ICS 和 DBM 移植的总体成功率分别为 85.7%（24/28）和 88.9%（24/27）（p＞0.05）。ICS 组完全愈合的平均时间为 17.3 周，DBM 组为 14.9 周（p＞0.05）。此外，除 1 例外，ICS 在 3 个月内完全吸收。
尽管 ICS 的吸收速度令人关注，但对于各种骨肿瘤手术中形成的骨缺损，注射用硫酸钙作为 DBM 基移植体的可替代骨移植材料具有成本更低、疗效相当的特点。
