Comparison of 2 Surgical Approaches in the Treatment of Degenerative Spondylolysthesis: Posterolateral Fusion With Instrumentation (GPLI) Plus or Minus Transforaminal Lumbar Interbody Fusion (TLIF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Success rate defined as fusion associated to at least a 3-degree increase of segmental lordosis angle and the absence of a reintervention due to a failure of the initial intervention
研究概览
简要总结
This trial, conducted in adult patients with degenerative spondylolisthesis needing surgical treatment at one level, aimed at comparing two approaches of spinal fusion.
详细描述
Degenerative spondylolisthesis is defined as the slip of one vertebra onto the other due to degenerative lesions; the L4-L5 intervertebral space is mainly involved. Mean age of symptomatic disease is about 60. Surgery is indicated in the presence of radiculalgia and/or neurological claudication and/or invalidating lombalgia, worsening neurological deficit, presence of sphincterian incontinence.
Surgical treatment of degenerative spondylolisthesis usually consists in neural decompression followed by posterolateral fusion with instrumentation. In the literature, fusion rate is estimated to be 80% with GPLI and seems to be increased by interbody fusion, especially transforaminal lumbar interbody fusion which has the advantage of unilateral disc interspace route, and fusion rate over 90%.
It seems that hypolordosis in the instrumented segments caused increased loading of the posterior column in the adjacent segments. These biomechanical effects may explain the degenerative changes at the junction level that have been observed as long-term consequences of lumbar fusion.
In addition to fusion, segmental lordosis gain seems to be an important long-term prognostic factor. Segmental lordosis recovery (upper than 3° in order to take into account measurement variability), was never assessed after TLIF procedure nor compared to that after posterolateral fusion in controlled randomized clinical trials.
The main objective of the study is the comparison of efficacy between circumferential fusion (TLIF plus GPLI) and GPLI alone as surgical treatment of degenerative spondylolisthesis in term of "Success" rate, defined as fusion and at least 3-degree increase of segmental lordosis angle, 24 months after surgery.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged less than 75,
- •Having been informed about clinical trial objectives and risk,
- •Covered by health insurance system,
- •Suffering from degenerative spondylolisthesis (whatever the grade and intervertebral disc height) needing one-level surgical fusion due to either invalidating lombalgia/radiculalgia despite 6-month optimal medical treatment and/or motor neurological symptoms.
排除标准
- •Previous lumbar fusion,
- •Previous spine traumatism,
- •Presence of at least one major contraindication to surgery and/or general anaesthesia (ie, non controlled coagulopathy, active infection, or serious underlying disease, auto-immune affection).
- •Presence of at least one contraindication to either TLIF or GPLI,
- •Severe radiological osteoporosis.
- •Active cancer at time of inclusion into the study.
- •Unlikely to comply with the requirements of the study and/or to complete the study for psychological, social, familial or geographical reasons.
- •Under any administrative or legal supervision.
研究组 & 干预措施
1
Posterolateral fusion with instrumentation combined to transforaminal lumbar interbody fusion
干预措施: Circumferential arthrodesis (Procedure)
2
Posterolateral fusion with instrumentation
干预措施: Posterolateral fusion with instrumentation (Procedure)
结局指标
主要结局
Success rate defined as fusion associated to at least a 3-degree increase of segmental lordosis angle and the absence of a reintervention due to a failure of the initial intervention
时间窗: 24 months after surgery
次要结局
- Functional outcome: Oswestry Disability Index and modified Prolo Economic and Functional scores(2, 6, 12 and 24 months after surgery)
- Quality of life outcome: SF-36(2, 6, 12 and 24 months after surgery)
- Change of pelvic and radiological parameters (ie, lumbar lordosis angle, medial intervertebral space height(2, 6, 12 and 24 months after surgery)
- Major complication (ie, life threatening haemorrhage, severe and persisting neurological worsening, deep infection) rate, and minor complication rate(within 24 months after surgery)
- Success rate defined as both fusion and at least 3-degree increase of segmental lordosis angle(6 and 12 months after surgery)
- Lumbar and radicular pain outcome(2, 6, 12 and 24 months after surgery)
- Per and post operative surgery parameters (ie, operative time, blood loss, hospitalization stay duration)(within hospital stay due to surgery)