第七页。轻度腰椎滑脱患者使用椎板间装置（Coflex®）的临床和放射学结果：一项单中心研究

IF 2.5 Q3 Medicine

North American Spine Society Journal Pub Date : 2025-07-01 DOI:10.1016/j.xnsj.2025.100631

Katrina Ysabel Naraval MD , Mikhail Lew Perez Ver MD

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引用次数: 0

摘要

背景：腰椎融合术可缓解退行性椎体滑脱（DLS）患者的疼痛，但术后存在风险，包括假关节和邻近节段退变和疾病，最终可能导致再次手术。动态稳定器，如Coflex®椎间装置，在确保稳定性的同时保持运动，提供症状缓解，减少并发症和降低风险。尽管研究各不相同，但最近的研究强调了它们对低度DLS的益处。目的：本研究评估Coflex®减压治疗低级别DLS后的放射学和临床效果，随访1至6年，以评估结果和并发症。研究设计/背景：这是一项来自单一三级中心的分析性回顾性队列研究，纳入了由两名接受过奖学金培训的脊柱外科医生在2017年1月1日至2023年6月31日期间进行腰椎减压并随后应用椎板间装置（Coflex®）治疗的轻度腰椎滑脱（Meyerding Gr I）患者。获得伦理许可（SL-23278）。47例轻度椎体滑脱（Meyerding Gr I）患者接受腰椎减压并应用椎间装置（Coflex®）治疗。结果测量获得影像学参数——腰椎前凸（LL）、下腰椎前凸（LL）、椎间盘高度（IDH）、椎间孔高度（IFH）和椎体平移（VT）。采用视觉模拟评分（VAS）和Oswestry残疾指数（ODI）评价临床结果。方法主要结果分为影像学和临床两大类。术前、术后、随访1年和随访1年分别评估影像学参数和功能指标。计算描述性统计（平均值、极差、标准差、频率、百分比）。配对Student*s t检验评估放射学参数和临床结果的差异。比较术前、术后即刻、12个月随访和最近随访（=1年）。复合对称的线性混合模型分析评估了随时间的显著变化。统计学意义设为p<；0.05.结果共纳入47例患者，平均年龄57岁，30 ~ 92岁，植入50个水平。手术减压和置入椎板间装置后，LL有轻微但不显著的下降[42.89°±10.08至40.33°±8.30 (p = 0.059)]并保持稳定，而LL保持不变。VT由3.82 mm±3.66 mm显著改善至1.53 mm±1.84 mm (p <；0.001)，并保持稳定，直到最后随访（p = 0.922）。IDH从10.23 mm±2.33显著增加到12.48 mm±3.11 (p <；0.001)， IFH从20.55 mm±3.40降至24.05 mm±3.78 (p <；0.001)，两者均在12个月时显著下降，但此后趋于稳定。临床结果，包括VAS （p = 0.006）和ODI (p = 0.002)，与基线相比有显著改善，并持续改善至最新随访。1例患者出现感染，无邻近节段疾病或下沉报告。结论：本研究表明，经后路椎板减压术和椎板间装置（Coflex®）治疗的低级别DLS患者在术后6年的主要放射学参数（包括LL、LL和VT）和脊柱运动方面取得并持续显著改善，且风险或并发症最小。术后观察到IDH和IFH的立即改善，在长期随访中只有轻微的变化。此外，研究结果显示背部疼痛和功能结果有所改善，与基线相比，VAS和ODI评分达到了最小的临床重要差异。FDA设备/药物状态coflex®Interlaminar设备（FDA PMA P110008）（批准用于该适应症）。

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P7. Clinical and radiologic outcomes of the use of interlaminar device (Coflex®) among patients with low-grade lumbar spondylolisthesis: a single center study

BACKGROUND CONTEXT

Lumbar spinal fusion relieves pain in degenerative spondylolisthesis (DLS) but carries postoperative risks, including pseudoarthrosis and adjacent segment degeneration and disease, which may eventually lead to reoperation. Dynamic stabilizers, like Coflex® interlaminar device, preserve motion while ensuring stability, providing symptom relief with fewer complications and a reduced risk profile. Though research varies, recent studies highlight their benefits in low-grade DLS.

PURPOSE

This study evaluated the radiologic and clinical effectiveness of Coflex® after decompression for low-grade DLS, with follow-ups at 1 to up to 6 years to assess outcomes and complications.

STUDY DESIGN/SETTING

This is an analytical retrospective cohort study from a single tertiary center including patients who had low-grade spondylolisthesis (Meyerding Gr I) and was treated with lumbar decompression with consequent interlaminar device (Coflex®) application performed by two fellowship-trained spine surgeons between January 1, 2017 and June 31, 2023. Ethical clearance was obtained (SL-23278).

PATIENT SAMPLE

Forty-seven patients who had low-grade spondylolisthesis (Meyerding Gr I) and treated with lumbar decompression with consequent interlaminar device (Coflex®) application were included.

OUTCOME MEASURES

Radiographic parameters – lumbar lordosis (LL), lower lumbar lordosis (LLL), intervertebral disc height (IDH), intervertebral foramen height (IFH), and vertebral translation (VT) – were obtained. Clinical outcomes were evaluated by visual analogue scale (VAS) and Oswestry disability Index (ODI).

METHODS

Primary outcomes were categorized as radiographic and clinical. Radiographic parameters and functional outcomes included were assessed preoperatively, postoperatively, at 1-year follow-up, and at =1-year follow-up. Descriptive statistics (mean, range, SD, frequency, percentage) were calculated. A paired Student*s t-test assessed differences in radiographic parameters and clinical outcomes. Comparisons were made across preoperative, immediate postoperative, 12-month follow-up, and latest follow-up (=1 year). Linear mixed model analysis with compound symmetry evaluated significant changes over time. Statistical significance was set at p< 0.05.

RESULTS

A total of 47 patients (mean age 57 years, range 30-92) with 50 implanted levels were included in the study. Following surgical decompression and interlaminar device placement, LL showed a slight but non-significant decrease [42.89° ± 10.08 to 40.33° ± 8.30 (p = 0.059)] and remained stable, while LLL remained unchanged. VT improved significantly from 3.82 mm ± 3.66 mm to 1.53 mm ± 1.84 mm (p < 0.001) and remained stable until the final follow-up (p = 0.922). IDH increased significantly from 10.23 mm ± 2.33 to 12.48 mm ± 3.11 (p < 0.001), and IFH from 20.55 mm ± 3.40 to 24.05 mm ± 3.78 (p < 0.001), both showing significant decreases at 12 months but stabilizing thereafter. Clinical outcomes, including VAS (p = 0.006) and ODI (p = 0.002), showed significant improvement compared to baseline, with continued improvement until the latest follow-up. One patient experienced infection, with no reports of adjacent segment disease or subsidence.

CONCLUSIONS

This study demonstrates that patients with low-grade DLS treated with posterior decompressive laminotomy and interlaminar device (Coflex®) achieve and sustain significant improvements in key radiologic parameters, including LL, LLL, and VT, and spinal motion for up to six years post-surgery with minimal risks or complications. Immediate postoperative improvements in IDH and IFH were observed, with only minor changes noted at long-term follow-up. Additionally, the findings show improvement in back pain and in functional outcomes, meeting the minimal clinically important differences for VAS and ODI scores compared to baseline.