混搭式活動性椎間支架與融合固定系統治療多節退化性腰椎椎間盤疾患的預後追蹤

Clinical outcome of a hybrid dynamic interspinous stabilization(Coflex™ ) and fusion system in multilevel lumbar degenerative disc disease

吳宗勳(Zong-Syun Wu)

指導教授 ： 黃旭霖

高雄醫學大學/醫學院/醫學研究所/臨床醫學組/碩士(2014年)

https://doi.org/10.6832/KMU.2014.00055

摘要

研究背景與目的 在過去幾十年來，腰椎融合手術不管有無使用固定物已經成為治療多節腰椎退化性椎間盤疾患的常見方法。然而，目前已有大量證據顯示融合的脊椎節段會對剩餘的脊椎節段產生不可想像的長期影響，特別是最接近的鄰近節段。多節腰椎退化性椎間盤疾患的嚴重度及不穩定程度是相當複雜的。因此對於這類患者使用包括活動性固定或非融合手術或混搭式手術( 針對不同節段採取活動性固定及融合手術 )的想法被提出。這個研究的目的是要評估多節腰椎退化性椎間盤疾患的病人使用混搭式活動性椎間支架(Coflex™ ) 與融合固定手術的臨床預後及在過渡節段及鄰近節段的活動改變。

研究方法 這個研究是分析在2010年10月至2011年12月因脊椎滑脫併鄰近節段狹窄接受後椎體融和固定及鄰近節段活動性支架固定手術的46位病人。所有病人都追蹤至少兩年的時間。我們使用視覺類比量表 (Visual Analogue Scale: VAS)(www.ericlin.com)來評估病人的背痛及下肢轉移痛程度。病患功能性評估則是使用Oswestry功能障礙指數（ODI）。

結果 這次研究包含32位女性及14位男性病患，平均年齡為63.4 ± 10.9歲。平均追蹤時間為30.6個月。術前的ODI及背痛及下肢轉移痛的VAS都有與術後做比較。融和的成功或失敗是經由一位獨立的醫師經由評估術後的X光片來評估。術後的背痛VAS由7.24±1.23減少至2.24±1.78 (p< 0.00003)，術後的下肢轉移痛VAS由7.03±1.64減少至2.58±1.5 (p< 0.0006)，術後的Oswestry功能障礙指數（ODI）由53.68±14.34% 改善為 24.37±13.2% (p< 0.00005)。術後鄰近節段活動度分析顯示有顯著意義的自然脊椎彎曲弧度增加(p<0.001)。進一步分析鄰近節段在彎曲方面活動度增加但伸展方面活動度則是有受限。而過度節段在術前及術後的活動度則是沒有統計意義上的改變。
結論 對於多節腰椎退化性椎間盤疾患使用混搭式活動性椎間支架( coflex-FR ) 與融合固定手術可以改善病患的臨床預後，造成腰椎融合的成功，維持過渡節段的活動度。它限制了鄰近節段的過度活動，尤其是正中往伸展方向。後續更多基礎及臨床的實驗來證實它是否能預防鄰近節段的退化是更需要的。

關鍵字

混搭式腰椎手術 ； 多節腰椎退化性椎間盤疾患 ； 融合及非融合 ； 鄰近節段退化

並列摘要

Objectives: Over the past decade, spinal arthrodesis with or without instrumentation has become a common technique for multilevel lumbar degenerative disc disease. However, evidence is growing that fusion may in fact have undesirable long-term effects on the remainder of the spine, particularly on the immediately adjacent motion segments. The severity of degeneration and instability in multilevel lumbar degenerative disc disease varies widely. Thus, a concept of dynamic or non-fusion stabilization or hybrid technique (segment-by-segment stabilization using dynamic stabilization and fusion) of the lumbar spine is emerged.
The objective of this study was to evaluate the clinical outcome and kinematic changes in bridged and adjacent segments of patients with multilevel lumbar degenerative disc disease treated using this segment-by-segment application of the interspinous device for segmental dynamic stabilization( Coflex™ ) in upper segment level as a non-fusion device and in lower segment level with a posterior lumbar interbody fusion.
Methods: This study analyzed 46 patients who had received posterior lumbar interbody fusion with posterior dynamic stabilization fixation for spondylolisthesis with adjacent level stenosis between Oct, 2010 and Dec, 2011. All patients were followed up for at least 2 years. Clinical characteristics were then retrospectively reviewed. The visual analog scale (VAS) was used to score both lower-limb pain and back pain. Patient functioning was evaluated using the Oswestry Disability Index (ODI).
Results: The sample included 32 females and 14 males with a mean age of 63.4 ± 10.9 years . Mean follow-up time was 30.6 months (range 25–38 months). Preoperative Oswestry disability index (ODI), back- and leg-pain scores (VAS) were compared to postoperative status. Fusion success and system failure were assessed by an independent reviewer who analyzed AP and lateral X-rays. Back pain improved from 7.24±1.23 to 2.24±1.78 (p< 0.00003), leg pain from 7.03±1.64 to 2.58±1.5 (p< 0.0006), and ODI from 53.68±14.34% to 24.37±13.2% (p< 0.00005). Analyses of adjacent segment motion after surgery showed significant increases inneutral lordotic curves (p<0.001). Whereas the adjacent segment tended to show flextion hypermobility but limited extension, ROM measured in the bridged segment before and after surgery did not significantly change.
Conclusion: A hybrid dynamic interspinous stabilization(Coflex™ ) with interbody fusion system for treating multilevel degenerative lumbar disc disease improves clinical outcomes, enables successful interbody fusion, and maintains range of motion (ROM) in the bridged segment. It limits the hypermobility in the adjacent segment, especially from neutral to extension. Further in vivo and in vitro experiments to if this system could prevent adjacent segment degeneration are needed.

並列關鍵字

Hybrid lumbar spine surgery ； multilevel degenerative lumbar disc disease ； fusion and non-fusion ； adjacent segment degeneration

參考文獻

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