Department of Orthopaedics, First Affiliated Hospital of Suzhou University, Suzhou, China.
Orthop Surg. 2009 Feb;1(1):17-21. doi: 10.1111/j.1757-7861.2008.00004.x.
To evaluate the safety and efficacy of early NovaBone grafting in accelerating healing of high-energy tibial shaft fractures.
In a prospective, randomized, controlled study 78 patients with open or closed tibial shaft fractures were treated with reamed interlocking nails, combined with NovaBone grafting. Forty patients were randomly assigned to the experimental group (with NovaBone grafting at fracture site), and 38 to the control group (without NovaBone grafting).
All patients were followed up for an average of 8 months (range 6-18 months). The average fracture healing time was 12 weeks (range 8-16 weeks) in the experimental group, and 19 weeks (range 12-36 weeks) in the control group (P < 0.01). No delayed union or nonunion was found in the experimental group, but four cases (10.5%) in the control group were found to heal spontaneously between 7 and 8 months. When the data were analyzed at week 12 and week 26 according to the criteria of Johner and Wruhs, 88% and 100% of the cases in the experimental group were rated as excellent and good respectively, but in the control group, 50% and 89% were rated as excellent and good respectively, these being significant differences (P < 0.05).
Internal fixation supplemented with early prophylactic NovaBone grafting of high-energy tibial shaft fractures is a safe and effective treatment which accelerates fracture healing.
评估早期 NovaBone 移植物植入加速高能胫骨骨折愈合的安全性和有效性。
在一项前瞻性、随机、对照研究中,78 例开放性或闭合性胫骨骨干骨折患者采用扩髓交锁髓内钉治疗,联合 NovaBone 移植物植入。40 例患者被随机分配到实验组(骨折部位行 NovaBone 移植物植入),38 例患者分到对照组(骨折部位不植入 NovaBone 移植物)。
所有患者平均随访 8 个月(6-18 个月)。实验组平均骨折愈合时间为 12 周(8-16 周),对照组为 19 周(12-36 周)(P<0.01)。实验组未发现延迟愈合或不愈合,但对照组有 4 例(10.5%)在 7-8 个月时自发性愈合。根据 Johner 和 Wruhs 标准在第 12 周和第 26 周进行数据分析时,实验组分别有 88%和 100%的病例被评为优和良,而对照组分别有 50%和 89%的病例被评为优和良,差异有统计学意义(P<0.05)。
高能胫骨骨干骨折内固定联合早期预防性 NovaBone 移植物植入是一种安全有效的治疗方法,可加速骨折愈合。