新型手持牵开器辅助下经Wiltse 入路与后路 TLIF 治疗腰椎间融合术的比较：一项为期一年的前瞻性对照研究。
Comparison of a novel hand-held retractor-assisted transforaminal lumbar interbody fusion by the wiltse approach and posterior TLIF: a one-year prospective controlled study.
机构信息
Division of Spinal Surgery, Department of Orthopaedics, Nanfang Hospital, Southern Medical University, 1838 North Guangzhou Avenue, Guangzhou, China.
Center for Orthopaedic Surgery, The Third Affiliated Hospital of Southern Medical University, Guangzhou, China.
出版信息
BMC Musculoskelet Disord. 2024 Feb 14;25(1):142. doi: 10.1186/s12891-024-07248-w.
BACKGROUND
This study aims to compare the clinical outcomes and safety of a novel hand-held retractor system-assisted Wiltse TLIF with that P-TLIF and assess whether this hand-held retractor system assisted Wiltse TLIF can yield less paraspinal muscle injury.
METHODS
56 patients (P-TLIF: 26, Wiltse TLIF: 30) were included in this one year prospective controlled study. The operation time, intraoperative blood loss, postoperative drainage, mobilization time, and discharge time were recorded. The clinical outcomes were evaluated by ODI, VAS, JOA, and SF-36 scores (7 days, 3, 6, and 12 months after surgery). Paraspinal muscle injury was assessed by postoperative MRI (6 months after surgery). CK and C-reaction protein were measured pre and postoperatively, and CT or X-ray (one year postoperatively) was used to assess bony union/non-union.
RESULTS
The Wiltse (study) group was associated with significantly less estimated blood loss (79.67 ± 28.59 ml vs 192.31 ± 59.48 ml, P = 0.000*), postoperative drainage (43.33 ± 27.89 ml vs 285.57 ± 123.05 ml, P = 0.000*), and shorter mobilization (4.1 ± 1.2 d vs. 3.0 ± 0.9 d, P < 0.05) and discharge times (7.7 ± 1.9 d vs. 6.1 ± 1.2 d, P = 0.002*) than the P-TLIF (control) group. Serum CK activity at 24 h postoperatively in the study group was significantly lower than in the control group (384.10 ± 141.99 U/L vs 532.76 ± 225.76 U/L, P = 0.018*). At 7 days after surgery, VAS (2.3 ± 0.6 vs 3.2 ± 0.7, P = 0.000*)and ODI scores (43.9 ± 11.9 vs 55.2 ± 12.9, P = 0.001*) were lower, while the JOA scores (18.4 ± 3.4 vs 16.3 ± 4.2, P = 0.041*) was higher in the control group than in the study group. Results observed at 3 months of follow-up were consistent with those at 7 days. After six months postoperatively, paraspinal muscle degeneration in the control group was more significant than in the study group (P = 0.008*).
CONCLUSION
Our study showed that this novel hand-held retractor system assisted Wiltse approach TLIF can significantly reduce paraspinal muscle injury, postoperative drainage, and intraoperative blood loss, mobilization and discharge time, as well as yield better short-term outcomes compared to P-TLIF.
TRIAL REGISTRATION
25/09/2023 NCT06052579.
背景
本研究旨在比较新型手持牵开器辅助 Wiltse 经椎间孔腰椎间融合术（TLIF）与传统经皮椎间孔腰椎间融合术（P-TLIF）的临床疗效和安全性，并评估该手持牵开器辅助 Wiltse TLIF 是否能减少椎旁肌损伤。
方法
将 56 例患者（P-TLIF：26 例，Wiltse TLIF：30 例）纳入本前瞻性对照研究。记录手术时间、术中出血量、术后引流量、下床活动时间和出院时间。采用 ODI、VAS、JOA 和 SF-36 评分（术后 7 天、3 个月、6 个月和 12 个月）评估临床疗效。术后 6 个月采用 MRI 评估椎旁肌损伤。术前和术后检测血清 CK 和 C 反应蛋白，术后 1 年采用 CT 或 X 线（术后 1 年）评估骨融合/不融合情况。
结果
与 P-TLIF（对照组）组相比，Wiltse（研究）组的估计出血量（79.67±28.59 ml 比 192.31±59.48 ml，P=0.000*）、术后引流（43.33±27.89 ml 比 285.57±123.05 ml，P=0.000*）、下床活动（4.1±1.2 d 比 3.0±0.9 d，P<0.05）和出院时间（7.7±1.9 d 比 6.1±1.2 d，P=0.002*）更短。术后 24 小时血清 CK 活性在研究组明显低于对照组（384.10±141.99 U/L 比 532.76±225.76 U/L，P=0.018*）。术后 7 天，VAS（2.3±0.6 比 3.2±0.7，P=0.000*）和 ODI 评分（43.9±11.9 比 55.2±12.9，P=0.001*）较低，JOA 评分（18.4±3.4 比 16.3±4.2，P=0.041*）较高。术后 3 个月的随访结果与术后 7 天的结果一致。术后 6 个月时，对照组的椎旁肌退变程度明显大于研究组（P=0.008*）。
结论
与 P-TLIF 相比，新型手持牵开器辅助 Wiltse 入路 TLIF 可显著减少椎旁肌损伤、术后引流和术中出血量，缩短下床活动和出院时间，且短期疗效更佳。
试验注册
25/09/2023 NCT06052579。
Zotero 插件