The Lumbar Adjacent Segment Stenosis (LASS) Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 192
- 试验地点
- 3
- 主要终点
- Oswestry Disability Index (ODI): Change in percent
研究概览
简要总结
The goal of this clinical trial is to learn if there are differences in the effectiveness of decompression surgery alone versus decompression combined with extended fusion in patients with a previous lumbar spinal fusion who now present with symptoms of lumbar adjacent segment stenosis (LASS). The main questions it aims to answer are:
- Does decompression alone differ from decompression combined with extended fusion with regard to clinical outcomes two years after surgery?
- Are there any clinical or radiological characteristics that can predict better or worse outcomes two years after surgery?
- Are there any differences between the treatment groups in terms of health economics?
Researchers will compare decompression surgery alone versus decompression combined with extended fusion to see if there are any differences in treatment effect.
Participants will:
- Be randomized to one of the two surgical procedures
- Visit the clinic four times postoperatively (at three months, 1, 2 and 5 years) for checkups and tests
- Respond to questionnaires before surgery, and three months, 1, 2 and 5 years postoperatively
详细描述
Globally, musculoskeletal disorders are the leading causes of years lived with disability, with spinal disorders contributing to 70% of this burden. The consequences for patients, their families and society are significant.
Lumbar spinal stenosis is a common condition with an increasing prevalence, largely due to an aging population. It is caused by degenerative changes in the supporting structures of the lumbar spine leading to symptoms like low-back pain and radiating pain to the lower extremities as well as numbness and weakness causing walking restrictions. Annually, about 200,000 to 250,000 new cases are diagnosed in the United States alone and this condition is the most frequent indication for spinal surgery in patients older than 65 years of age. Approximately 10% of the population over 50 years suffer from symptomatic lumbar spinal stenosis.
Lumbar surgery may be indicated in patients with various degenerative spinal conditions when non-surgical treatment has failed, and radiological findings are consistent with clinical symptoms. Decompression (removal of stenotic structures to relieve nerve pressure) and spinal fusion (the use of screws, rods, plates, or other devices to assist in achieving fusion between vertebral bodies) remain the cornerstone of operative treatment. The volume of lumbar spine surgery has increased considerably over the past decades, particularly for more complex procedures such as instrumented fusion, and especially among the elderly. In the United States, the hospital costs of lumbar instrumented fusion procedures is reported to be higher than for any other surgical procedure such as percutaneous coronary angioplasty and knee- and hip arthroplasty. In Norway, approximately 700 lumbar spinal fusions are performed every year, with about half of them being reoperations.
Lumbar spinal fusion has the highest complication rates among all spinal surgeries. Complications involving either the segment above or below (=adjacent to) a previously fused segment can arise years after the initial fusion. An annual incidence of 2,5-4% for new subsequent surgery after initial lumbar fusion is reported, 13.6% and 22.2% were re-operated within 5 and 10 years respectively. The majority of reoperations following an initial fusion are due to spinal stenosis adjacent to a previously fused segment (Lumbar Adjacent Segment Stenosis - LASS), and these patients constitute a substantial subgroup within the extensive and growing patient population with spinal stenosis.
At present, there are no guidelines or prospective studies that can advise clinicians on how patients with LASS should be treated, and this issue is emerging as one of the most relevant and debated questions within degenerative spine surgery. According to register data, the most common treatments are either extending the fusion beyond the symptomatic adjacent stenotic segment or just decompression of the stenotic structures, with a tendency of performing just decompression in patients with cranial LASS and decompression with extended fusion in patients with caudal LASS. However, there is large variation in surgical practices both between and even within hospitals. Considering the increasing prevalence of LASS, costs, and risks associated with spinal fusions, there is need for randomized trials to evaluate surgical practice and the relative efficacy of the two most common surgical treatments.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The trial is open-label for participants, caregivers (surgeons and clinical staff). But investigators, outcome assessors and the statistician will be blinded to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all the following criteria to be eligible for the study:
- •Clinical symptoms of spinal stenosis, defined as neurogenic claudication or radiating pain into the lower limbs with duration >6 months
- •MRI-confirmed adjacent segment stenosis, proximal to a previously fused lumbar segment (fusion of maximum two levels between L1 and S1, any type of previous lumbar fixation procedure).
- •CT-verified solid fusion
- •Minimum time since previous fusion: one year
- •Eligible for both treatment alternatives: decompression with extended fusion and decompression alone.
- •Age between 18 and 80 years.
- •Insufficient improvement after at least 3 months of non-operative treatment.
- •Understand Norwegian language, spoken and written.
排除标准
- •Participants will be excluded if any of the following criteria are met:
- •Previous surgery at the actual adjacent stenotic level.
- •More than two fused lumbar levels.
- •Non-union (pseudoarthrosis) at the previously surgically fused level, radiologically verified.
- •Foraminal stenosis grade 3 at the adjacent level.
- •Spinal fracture.
- •Presence of cauda equina syndrome.
- •Complete motor deficit.
- •ASA physical status classification IV or V.
- •Alcohol or drug abuse.
- •Active cancer
- •Contradictions to MRI (e.g., Cardiac pacemaker electrodes, metal implants in the eye or brain, claustrophobia)
- •Disabling chronic neurological disease (e.g., Parkinson's disease, ALS, MS)
- •Ongoing serious psychiatric disease&
- •Any condition that in the view of the investigator would suggest that the patient is unable to comply with the study protocol and procedures
- •Declining specific treatment arm
- •Are participating in another clinical trial that may interfere with this trial
结局指标
主要结局
Oswestry Disability Index (ODI): Change in percent
时间窗: From enrollment to five years postoperatively (main endpoint is two years after surgery, but ODI will also be assessed before surgery, 3 months, one- and five years postoperatively)
Improvement in the ODI score of a minimum of 30% from baseline (dichotomized variable: yes / no (yes = improved 30% or more, no = improved less than 30%)). The ODI is a questionnaire examin the level of disability based on 10 everyday activities of daily living. Each item consists of 6 statements which are scored from 0 to 5, with 0 indicating the least disability and 5 the highest level of disability. The total score is calculated as a percentage, with 0% indicating no disability and 100% indicating the highest level of disability.
次要结局
- Oswestry Disability Index (ODI): Continuous(From enrollment to five years postoperatively (main endpoint is two years after surgery, but ODI will also be assessed before surgery, 3 months, one- and five years postoperatively))
- Numeric Rating Scale leg pain (NRS leg pain)(From enrollment to five years postoperatively (main endpoint is two years after surgery, but NRS leg pain will also be assessed before surgery, 3 months, one- and five years postoperatively))
- Numeric Rating Scale back pain (NRS back pain)(From enrollment to five years postoperatively (main endpoint is two years after surgery, but NRS back pain will also be assessed before surgery, 3 months, one- and five years postoperatively))
- Global perceived effect (GPE)(From three months after surgery to five years postoperatively (main endpoint is two years after surgery, but GPE will also be assessed 3 months, one- and five years postoperatively))
- Oswestry Disability Index (ODI): Change in percent(From enrollment to five years postoperatively (main endpoint is two years after surgery, but ODI will also be assessed before surgery, 3 months, one- and five years postoperatively))
- EuroQol-5 dimensions-5 levels (EQ-5D-5L)(From enrollment to five years postoperatively (main endpoint is two years after surgery, but EQ-5D-5L will also be assessed before surgery, 3 months, one- and five years postoperatively))
- Occupational status and return to work(From enrollment to five years postoperatively (main endpoint is two years after surgery, but participants will also be asked about their occupational status before surgery, 3 months, one- and five years postoperatively))
- Radiology(From enrollment to five years postoperatively. Standing X-ray is taken six times (before surgery, postoperatively before discharge from hospital, and 3 months, 1 year, 2 years, and 5 years after surgery). CT 2 years after surgery (extended fusions only))
- Reoperations(During the whole study period (five years))
研究者
Kjersti Storheim
Head of section
Oslo University Hospital
