Department of Spine Surgery, St. Franziskus Hospital Muenster, Hohenzollernring 72, 48145 Muenster, Germany.
Eur Spine J. 2013 Mar;22 Suppl 2(Suppl 2):S185-94. doi: 10.1007/s00586-012-2485-7. Epub 2012 Sep 5.
The purpose of this prospective clinical study is to evaluate the clinical and radiographic outcomes using a silicate-substituted calcium phosphate (Si-CaP) as a bone graft substitute in surgery for adolescent idiopathic scoliosis (AIS). In posterior corrective surgery for AIS, harvesting autologous bone from the iliac crest still represents the gold standard to augment the local bone graft though it is comparatively invasive and associated with donor site morbidity. Si-CaP enriched with bone marrow aspirate (BMA) might be an appropriate bone graft extender to overcome these difficulties.
Eighteen female and three male patients with AIS who underwent corrective posterior instrumentation were observed clinically and radiographically for a minimum of 24 months. In all cases, 20-40 ml Si-CaP granules (ACTIFUSE) mixed with BMA from vertebral bodies was used to extend the local bone graft. Fusion was assessed by standardized conventional radiographs regarding loss of correction and implant failure. Clinical outcome was evaluated with use of the Scoliosis Research Society-22 patient Questionnaire (SRS-22) and a Visual Analog Scale (VAS) for back pain.
Cobb angle of major curves averaged 63° preoperatively, 22° after surgery, and 24° at final follow-up, with a maximum loss of correction of 7° recorded after 4 months. No adverse effects related to the study material had been observed. In all patients, there was no evidence of implant failure, and formation of an increasingly densifying 'fusion mass' was visible, as assessed by conventional radiography. VAS score for back pain averaged 1.7 before surgery, 2.3 at discharge, and 1.5 at final follow-up. Outcome assessment using the SRS-22 revealed a significantly enhanced overall health-related quality of life (84 vs. 74 % before surgery; P = 0.0005) due to a significant improvement of the domains 'self image' (77 vs. 59 %; P = 0.0002) and 'pain' (88 vs. 80 %; P = 0.02). Patients' management satisfaction averaged 93 %.
Si-CaP augmented with BMA from vertebral bodies seems to prove an effective, safe, and easy to handle bone graft extender in scoliosis surgery and thus a suitable alternative to bone harvesting procedures.
本前瞻性临床研究旨在评估使用硅取代钙磷(Si-CaP)作为骨移植物替代物在青少年特发性脊柱侧凸(AIS)手术中的临床和影像学结果。在 AIS 的后路矫正手术中,从髂嵴采集自体骨仍然是增强局部骨移植物的金标准,尽管它相对具有侵入性且与供体部位发病率相关。富含骨髓抽吸物(BMA)的 Si-CaP 可能是克服这些困难的合适的骨移植物延伸剂。
18 名女性和 3 名男性 AIS 患者接受了后路矫正器械治疗,至少随访 24 个月进行临床和影像学评估。在所有病例中,使用 20-40ml 的 Si-CaP 颗粒(ACTIFUSE)与来自椎体的 BMA 混合,以扩展局部骨移植物。通过标准的常规 X 射线评估融合情况,包括矫正丢失和植入物失败。临床结果使用脊柱侧凸研究协会 22 项患者问卷(SRS-22)和背部疼痛视觉模拟量表(VAS)进行评估。
主要曲线的 Cobb 角术前平均为 63°,术后为 22°,最终随访时为 24°,术后 4 个月时记录的最大矫正丢失为 7°。未观察到与研究材料相关的不良反应。在所有患者中,均未发现植入物失败的证据,并且通过常规 X 射线评估,可见形成越来越密集的“融合块”。背部疼痛的 VAS 评分术前平均为 1.7,出院时为 2.3,最终随访时为 1.5。使用 SRS-22 进行的结果评估显示,由于“自我形象”(77%比 59%;P=0.0002)和“疼痛”(88%比 80%;P=0.02)领域的显著改善,整体健康相关生活质量显著提高(术前 84%比 74%;P=0.0005)。患者管理满意度平均为 93%。
用椎体的 BMA 增强的 Si-CaP 似乎是一种有效的、安全的、易于处理的脊柱侧凸手术中的骨移植物延伸剂,因此是骨采集程序的合适替代方法。