钛合金骨小梁融合器在单节段腰椎融合术中应用的短期临床疗效观察

The short-term clinical efficacy of trabecular titanium fusion cages in single-level lumbar fusion surgery

中文关键词:  腰椎退行性病变  腰椎椎体间融合术  融合器  钛合金  椎间隙高度

英文关键词:Lumbar degenerative disease  Lumbar interbody fusion  Fusion cage  Titanium alloy  Disc height

中文摘要:

  【摘要】 目的：探讨钛合金骨小梁椎间融合器在单节段腰椎后路减压植骨融合内固定中的应用及短期临床疗效。方法：回顾性分析2022年6月~2023年6月在上海市徐汇区中心医院骨科行单节段腰椎后路减压植骨融合内固定术的68例患者，其中32例使用钛合金骨小梁椎间融合器，纳入钛合金组，男12例，女20例，年龄60.9±10.4岁，其中骨质疏松患者12例；融合节段：L3/4 2例，L4/5 27例，L5/S1 3例。36例使用聚醚醚酮（polyetheretherketone，PEEK）椎间融合器，纳入PEEK组，男10例，女26例，年龄62.9±9.1岁，其中骨质疏松患者12例；融合节段：L3/4 2例，L4/5 29例，L5/S1 5例。术后随访24~30个月（26.8±1.8个月），分别记录两组患者术前、术后及末次随访时的疼痛视觉模拟量表（visual analog scale，VAS）评分和Oswestry功能障碍指数（Oswestry disability index，ODI），比较两组患者手术时间、术中出血量、术后引流量、住院时间及术后至末次随访时的并发症发生情况。应用腰椎前凸角（lumbar lordosis，LL）、椎间隙高度（disc height，DH）变化、融合器沉降及椎间融合情况等指标，评估两种融合器对腰椎DH、LL的改善及维持水平。结果：所有患者均顺利完成手术，两组患者手术时间、术中出血量、术后引流量、住院时间均无统计学差异（P>0.05）。钛合金组术前、术后和末次随访时的VAS评分分别为6.88±1.07分、3.31±0.97分和1.06±0.80分，DH分别为8.74±2.42mm、12.17±1.38mm和11.63±1.27mm，LL分别为40.47°±15.10°、38.34°±10.49°和39.86°±12.53°；PEEK组分别为6.83±1.05分、3.08±0.81分和0.92±0.84分，8.57±2.30mm、11.17±1.28mm和9.76±1.15mm，47.10°±14.26°、42.46°±13.02°和39.33°±13.39°；钛合金组术前和末次随访时的ODI分别为40.67±6.06分和19.46±2.31分，PEEK组分别为37.95±5.19分和18.90±3.29分。两组术后即刻和末次随访时的VAS评分和末次随访时的ODI均较术前显著性改善（P<0.05）；两组间同时点VAS评分和ODI比较均无显著性差异（P>0.05）；两组术后DH均较术前显著性增加（P<0.05）；钛合金组末次随访时的LL丢失值及DH丢失值均小于PEEK组，椎间融合器沉降率低于PEEK组，差异具有统计学意义（P<0.05）。末次随访时，钛合金组患者融合率为100%，PEEK组的融合率为91.7%（33/36），差异无统计学意义（P>0.05），节段未完全融合患者均无显著腰痛等不适。两组患者在术后随访期间均未出现内固定物断裂、松动、移位等情况。结论：与PEEK融合器相比，在单节段腰椎融合术中使用钛合金骨小梁椎间融合器具有良好的融合效果，可恢复并维持LL和DH，具有良好的抗沉降性，能降低DH丢失的程度。

英文摘要:

  【Abstract】 Objectives: To explore the application and short-term clinical efficacy of titanium alloy trabecular interbody cage in single-level posterior lumbar decompression, bone graft fusion and internal fixation. Methods: A retrospective analysis was conducted on 68 patients undergone single-level posterior lumbar decompression, bone graft fusion and internal fixation between June 2022 and June 2023 at the Department of Orthopaedics, Shanghai Xuhui District Central Hospital. 32 patients received the titanium alloy trabecular cage were included into the titanium group, which consisted of 12 males and 20 females, aged 60.9±10.4 years, and 12 were diagnosed with osteoporosis; Fusion levels: L3/4 in 2, L4/5 in 27, L5/S1 in 3. 36 patients received the polyetheretherketone(PEEK) cage were included into the PEEK group, and there were 10 males and 26 females, aged 62.9±9.1 years, among them 12 were diagnosed with osteoporosis; Fusion levels: L3/4 in 2, L4/5 in 29, L5/S1 in 5. The patients were followed up for 24-30months(26.8±1.8 months). Preoperative, postoperative, and final follow-up visual analog scale(VAS) scores and Oswestry disability index(ODI) were recorded. Operative time, intraoperative blood loss, postoperative drainage, hospital stay, and complications after operation till the final follow-up were compared. Radiographic parameters, including lumbar lordosis(LL), disc height(DH), incidence of cage subsidence, and interbody fusion rate, were assessed to evaluate the improvement and maintenance of LL and DH. Results: All surgeries were completed successfully. There were no significant differences between the two groups in operative time, blood loss, postoperative drainage, and hospital stay(P>0.05). In the titanium group, the VAS scores were 6.88±1.07 preoperatively, 3.31±0.97 postoperatively, and 1.06±0.80 at final follow-up; DH values were 8.74±2.42mm, 12.17±1.38mm, and 11.63±1.27mm, respectively; LL values were 40.47°±15.10°, 38.34°±10.49°, and 39.86°±12.53°, respectively. In the PEEK group, the VAS scores were 6.83±1.05, 3.08±0.81, and 0.92±0.84; DH values were 8.57±2.30mm, 11.17±1.28mm, and 9.76±1.15mm; LL values were 47.10°±14.26°, 42.46°±13.02°, and 39.33°±13.39°, respectively. ODI improved from 40.67±6.06 preoperatively to 19.46±2.31 at final follow-up in titanium group, and from 37.95±5.19 to 18.90±3.29 in the PEEK group. Both groups showed significant improvements in VAS scores and ODI at postoperative immediately and final follow-up compared with baseline(P<0.05), with no inter-group differences at the corresponding time points(P>0.05). Postoperative DH was significantly increased compared with preoperative values in both groups(P<0.05). At final follow-up, the losses of LL and DH, as well as the cage subsidence rate were significantly lower in the titanium group than in the PEEK group(P<0.05). The fusion rate was 100% in the titanium group and 91.7%(33/36) in the PEEK group, with no statistical difference(P>0.05); Patients with incomplete fusion had no significant low back pain. No implant breakage, loosening, or migration occurred in either group during follow-up. Conclusions: Compared with PEEK cage, the titanium alloy trabecular interbody cage can yield a favorable fusion effect in single-level lumbar fusion surgery, restore and maintain LL and DH. It has a good anti-subsidence property and can reduce the magnitude of DH loss.