髓芯减压联合纳米羟基磷灰石/聚酰胺66杆治疗股骨头坏死的前瞻性研究

目的 探讨髓芯减压联合纳米羟基磷灰石/聚酰胺66(n-HA/PA66)杆及多孔生物玻璃骨移植物治疗股骨头坏死的效果。方法 本实验为前瞻性研究。纳入西安交通大学第二附属医院骨一科2009年1月—2013年7月收治的股骨头坏死患者64例(84髋),采用信封法行简单随机分组,分为髓芯减压联合n-HA/PA66杆及多孔生物玻璃骨移植物组(治疗组,29例38髋)及髓芯减压联合自体松质骨移植组(对照组,35例46髋)。收集两组患者的临床及影像学资料,比较两组患者手术前后Harris髋关节评分(HHS)、VAS及其变化,随访终点时临床及影像学失败率,并应用生存曲线分析两组髋关节生存率。结果 两组患者术前VAS、HHS评分差异均无统计学意义(P值均>0.05);随访终点时,治疗组VAS、HHS评分均优于对照组(P值均<0.01);与术前比较,两组随访终点VAS、HHS评分有显著改善(P值均＜0.01)。两组除Steinberg ⅡB、ⅡC、ⅢA患者间术前与术后随访终点HHS评分的变化差异均有统计学意义(t=2.901、2.242、4.435,P值均＜0.05)外,其余分期两组间差异均无统计学意义(P值均>0.05)。两组除Steinberg ⅡB、ⅡC、ⅢA患者间术前与术后随访终点VAS评分的变化差异有统计学意义(t=2.933、2.119、3.513,P值均＜0.05)外,其余分期两组间差异均无统计学意义(P值均>0.05)。Kaplan-Meier生存曲线发现,在随访期内治疗组髋关节生存率高于对照组,经Log-rank检验提示两组之间髋关节生存率差异有统计学意义( χ²=6.753,P<0.05)。治疗组影像学失败率为21.05%(8/38),低于对照组的45.65%(21/46);临床失败率23.68%(9/38),亦低于对照组的52.17%(24/46);差异均有统计学意义( χ²=5.571、7.081,P值均＜0.05)。结论 髓芯减压联合n-HA/PA66杆及多孔生物玻璃骨移植物法可以显著缓解股骨头坏死患者髋关节疼痛,改善髋关节功能,并阻止股骨头塌陷。由于本手术方法对股骨头坏死治疗效果可能与其Steinberg分期有关,推荐将该方法应用于早、中期股骨头坏死患者。

Core decompression combined with nano hydroxyapatite/polyamide 66 rod for the treatment of osteonecrosis of the femoral head

Objective To investigate the effectiveness of core decompression in combination with a nano-hydroxyapatite/polyamide 66 (n-HA/PA66) rod and a porous bioglass bone graft for the treatment of osteonecrosis of the femoral head (ONFH). Methods A prospectively designed algorithm was applied retrospectively to a cohort of sixty-four patients (84 hips) with ONFH, which were treated from 2009 to 2013 in the Department of Orthopaedics, the Second Affiliated Hospital of Xian Jiaotong University. These hips were allocated to a program of either core decompression core decomp-copy in combination with a n-HA/PA66 rod and a porous bio-glass bone graft (treatment group, 29 patients with 38 hips) or core decompression with an autologous cancellous bone graft (control group, 35 patients with 46 hips). Clinical and radiographic retrospective follow-ups were performed on all patients with the prospectively collected data. The HHS, VAS and survival-rate of implants were compared respectively. Results No significant difference was observed between two groups on HHS and VAS scores(all P values＞0.05). HHS and VAS scores of treatment group were significantly improved than those of control group(all P values＜0.01). HHS and VAS scores were increased significantly in both groups post-surgery (all P values<0.01). There was a significant difference between the two groups on HHS improvement for Steinberg ⅡB, ⅡC, and ⅢA (t=2.901, 2.242, 4.435, all P values<0.05) while other stages had no significant difference(all P values＞0.05). Significant difference in the VAS improvement was observed between the groups for ⅡB, ⅡC and ⅢA (t=2.933, 2.119, 3.513, all P values<0.05) but did not detect in reminder stages(all P values＞0.05). Further analysis of Kaplan-Meier curves found that implants survival of treatment group was higher than that of control group, which was proved significantly different by Log-rank test(χ²=6.753, P<0.05). Imaging failure rate of treatment group was 21.05%(8/38), which was lower than that of control group (45.65%, 21/46), while clinical failure of treatment group was also lower than that of control group 23.68%(9/38) vs 52.17%(24/46)], and both difference had statistical significance (χ²=5.571, 7.081, all P values< 0.05). Conclusions Core decompression combined with the implantation of a n-HA/PA66 rod and a bioglass bone graft can significantly decrease hip pain, improve hip function, and prevent the collapse of the femoral head in patients with ONFH. As the effectiveness of this approach appears to vary with Steinberg stage, we suggest that this treatment procedure may be suitable for patients with early to middle stage ONFH.