Heo Juneyoung, Baek Ji-Hoon, Kim Ji Hyun, Chang Jae Chil, Park Hyung-Ki, Lee Su Chan
Joint & Arthritis Research, Department of Neurosurgery, Himchan Hospital, Seoul 07999, Republic of Korea.
Joint & Arthritis Research, Department of Orthopaedic Surgery, Himchan Hospital, Seoul 07999, Republic of Korea.
J Clin Med. 2025 Apr 21;14(8):2856. doi: 10.3390/jcm14082856.
This study aimed to evaluate the long-term clinical usefulness and radiologic changes around the Coflex device following decompression with Coflex insertion for degenerative lumbar spinal stenosis (DLSS), with an average follow-up of 14 years. This retrospective study included 147 patients who underwent decompression and Coflex insertion for single-level DLSS at a single institution between January 2007 and December 2010. Patients with spinal stenosis unresponsive to 3 months of conservative treatment were treated surgically. The mean follow-up duration was 173.9 ± 23.7 (range, 119-214) months. The mean visual analog scale score decreased from 8.22 ± 1.06 preoperatively to 2.08 ± 1.58 postoperatively. Intervertebral disc height and foramen height at the Coflex insertion site decreased by 5.3% and 2.0%, respectively, after surgery. The reoperation rate at the operated site was 25% ( = 37). A significantly higher reoperation rate was observed in patients with translational instability (odds ratio [OR], 7.77; 95% confidence interval [CI], 2.453-24.658; < 0.01) and angular instability (OR, 1.59; 95% CI, 0.492-5.133; < 0.001). Eight patients underwent reoperation due to rapid progression of instability within 2 years of Coflex insertion; thereafter, a similar cumulative incidence rate was consistently observed. The adjacent-segment reoperation rate was 10.8% ( = 16). The Coflex interspinous device helps preserve disc and foramen height but is associated with a high reoperation rate, particularly in patients with spinal instability. Therefore, careful patient selection is crucial when considering its use.
本研究旨在评估采用Coflex装置减压并植入Coflex治疗退变性腰椎管狭窄症（DLSS）后的长期临床效用及该装置周围的放射学变化，平均随访时间为14年。这项回顾性研究纳入了2007年1月至2010年12月期间在单一机构接受单节段DLSS减压及Coflex植入手术的147例患者。对保守治疗3个月无效的椎管狭窄患者进行手术治疗。平均随访时间为173.9±23.7（范围119 - 214）个月。平均视觉模拟量表评分从术前的8.22±1.06降至术后的2.08±1.58。手术后，Coflex植入部位的椎间盘高度和椎间孔高度分别下降了5.3%和2.0%。手术部位的再次手术率为25%（n = 37）。在存在平移性不稳定的患者中观察到显著更高的再次手术率（优势比[OR]，7.77；95%置信区间[CI]，2.453 - 24.658；P < 0.01）以及角向不稳定的患者（OR，1.59；95% CI，0.492 - 5.133；P < 0.001）。8例患者在Coflex植入后2年内因不稳定快速进展而接受再次手术；此后，持续观察到类似的累积发生率。相邻节段再次手术率为10.8%（n = 16）。Coflex棘突间装置有助于保留椎间盘和椎间孔高度，但与高再次手术率相关，尤其是在脊柱不稳定的患者中。因此，在考虑使用该装置时，仔细选择患者至关重要。
