跳至主要内容
临床试验/NCT04589572
NCT04589572暂停不适用

Structural and Funcional Outcomes of Extreme Lateral Interbody Fusion (XLIF) Compared to Posterior Lumbar Interbody Fusion (PLIF)

Hasselt University6 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
40
试验地点
6
主要终点
Paraspinal muscle biopsy

研究概览

简要总结

Since the first successful spinal fusion surgery using a modern stabilization technique in 1909, surgical fusion has become one of the most commonly performed procedures for degenerative disease of the lumbar spine. The incidence of lumbar spinal fusion for degenerative conditions has more than doubled from 2000 until 2009. Despite the high incidence of fusion surgery, the decision making in lumbar fusion surgery is complicated by a wide variety of indications (the greatest measured in any surgical procedure). This could indicate there might be an overuse of lumbar fusion. However, decompression alone, or non-operative care for degenerative conditions may risk progressive spinal instability, intractable pain, and neurological impairment. These complications in the absence of fusion surgery, clearly demonstrate the beneficial effects of adding spinal fusion surgery. Because of its beneficial effect and high usage, it is of greatest importance to reduce postoperative disability and pain, by diminishing surgical invasiveness.

Traditional open posterior lumbar interbody fusion (PLIF) or transforaminal lumbar interbody fusion (TLIF) are used to treat degenerative diseases of the spinal column. These techniques require an extensive dissection of the paraspinal musculature, which in term can lead to muscle denervation, loss of function, muscular atrophy, and spinal instability. It has also been known that paraspinal muscle damage induced during surgery is related to long term disability and pain. With this knowledge, minimally invasive spine surgery began to develop in the mid-twentieth century. Since then, new direct approaches to the lumbar spine, known as lumbar lateral interbody fusion (LLIF), direct lateral interbody fusion (DLIF), or extreme lateral interbody fusion (XLIF), have been introduced.

This study will focus on XLIF. Ozgur. 2006 first reported the XLIF procedure, as a minimally invasive procedure that approaches the spine from the lateral via the space between the 12th rib and the highest point of the iliac crest. This approach allows direct access to the intervertebral disc space without disruption of the peritoneal structures or posterior paraspinal musculature. Ohba. 2017 compared XLIF with percutaneous pedicle screws to traditional PLIF, and found that PLIF was associated with less intraoperative blood loss, postoperative white blood cell (WBC) counts, C-reactive protein (CRP) levels, and creatine kinases (CK) levels, indicating less muscle damage. Postoperative recovery of performance was significantly faster in the XLIF group. 1-year disability and pain scores were also significantly lower in the XLIF group. Despite these significant better results reported in the XLIF group, the systematic review of Barbagallo. 2015 concluded that there is insufficient evidence of the comparative effectiveness of lateral lumbar interbody fusion (XLIF) versus PLIF/ TLIF surgery. This indicates that the evidence for choosing between XLIF or a traditional approach is still scarce, and no recommendations can be made.

This study will focus on comparing XLIF to PLIF. The objective of this study is to compare clinical and structural outcome measures between the XLIF and PLIF groups, to confirm our hypothesis that the minimally invasiveness of the XLIF technique facilitates a significant faster post-operative recovery, and improves functional and structural outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical single level disc degeneration
  • Age between 18 and 65 years old
  • Understand Dutch (writing and speaking)
  • Symptom duration ≤ 5 years

排除标准

  • Involvement of the L5-S1 or L2-L3 segment
  • Psychiatric pathology/ problems (e.g. substance abuse)
  • Pregnancy
  • Being non-suitable for surgery
  • Other diagnosed neurological or musculoskeletal diseases that might affect the spinal column
  • Not being able to function independently (activities of daily living)

结局指标

主要结局

Paraspinal muscle biopsy

时间窗: week 8

From each participant a sample will be obtained from the lumbar multifidus and erector spinae muscle before (T0) and after lumbar surgery (T4). These samples will be obtained using a minimally invasive ultrasound guided percutaneous biopsy technique using a local anesthetic. The samples will be immediately frozen. After cutting these will be used for immunofluorescent staining for myosin heavy chain I, IIA, and IIX. These staining's will be analyzed to measure muscle fiber size and number. These data will be used to evaluate within and between group differences in atrophy or shift in muscle fiber typing.

concentration of C-Reactive Protein

时间窗: week 8

Blood analysis

concentration of Phosphate

时间窗: week 8

Blood analysis

concentration of Creatine kinase

时间窗: week 8

Blood analysis

concentration of Myoglobine

时间窗: week 8

Blood analysis

concentration of Lactate dehydrogenase

时间窗: week 8

Blood analysis

concentration of Calcium

时间窗: week 8

Blood analysis

concentration of Alkaline phosphatase

时间窗: week 8

Blood analysis

次要结局

  • Pain catastrophizing scale (PCS)(week 8)
  • Blood loss(week o)
  • Visual analogue scale (VAS)(week 8)
  • Pain vigilance and awareness questionnaire (PVAQ)(week 8)
  • Oswestry Disability Index (ODI)(week 8)
  • Physical Activities Scale For Individuals with Physical Disabilities (PASIPD)(week 8)
  • Magnetic Resonance Imaging (MRI)(week 8)
  • DEXA-san (Dual-energy X-ray Absorptiometry).(week 8)
  • activity tracker(From - 1 week up to week 8 (24 hours a day))
  • The Tampa Scale for Kinesiophobia (TSK)(week 8)
  • EQ5D questionaire(week 8)
  • The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)(week 8)
  • Dietary intake(up to week 8)
  • Operating time(week o)
  • Complications(week o)

研究者

发起方
Hasselt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Frank Vandenabeele

Principal Investigator

Hasselt University

研究点 (6)

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