Is Indirect Decompression Sufficient for the Treatment of Central Stenosis?: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Oswestry Disability Index (ODI)
研究概览
简要总结
This is a prospective, randomized clinical trial of patients undergoing 1-level lateral lumbar spinal fusion. This study seeks to randomize patients indicated for Lateral Lumbar Interbody Fusion (LLIF) into one of two groups: direct decompression and indirect decompression.
详细描述
While indirect decompression has been largely accepted as a strategy to treat foraminal stenosis, there is some disagreement regarding its efficacy in treating patients with central and lateral recess stenosis. The current study seeks to randomize patients indicated for Lateral Lumbar Interbody Fusion (LLIF) into one of two groups: direct decompression and indirect decompression. Enrolled participants will be evaluated before surgery, during their hospital course and post-operatively at 6 weeks, 3 months, 6 months, 1 and 2 years. Operative details, complications, reoperation rates, patient reported outcomes, clinical and radiographic outcome measures will be compared.
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
- Single (Participant)
盲法说明
Patients will be blinded to randomization and surgical technique will not be evident based on postoperative radiographs. Research coordinators, surgeons, principal investigator (assisting with randomization) and other co-investigators will not be blinded to the type of surgical procedure performed.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fusion indicated by the treating surgeon. Fusion may be indicated for one or more of the following reasons:
- •Mobile degenerative spondylolisthesis
- •Severe vertical foraminal stenosis
- •Adjacent segment degeneration and/or degenerative disc disease with suspected discogenic pain
- •One-level central canal stenosis
- •WITH neurogenic claudication
- •As measured in preoperative MRI
- •Oswestry Low Back Pain Disability Questionnaire score > 35% (18/50)
- •Failed 3 months of conservative treatment
- •Willing to give written informed consent and psychosocially, mentally, and physically able to comply fully with protocol, including adhering to follow-up schedule and requirements, and filling out forms
排除标准
- •Multilevel central canal stenosis
- •Patients with vertebral endplate dimensions that are too small to allow for safe placement of an intervertebral cage
- •Known allergy to titanium, polyethylene, cobalt, chromium, or molybdenum
- •Prior surgery at index disc level (discectomy, decompression, or fusion)
- •History of spinal or vertebral infection of the lumbar spine
- •History of vertebral fracture of the lumbar spine
- •Current pregnancy or interest in becoming pregnant over the next 1 year
- •Active infection-systemic or local
- •Non-English speakers
结局指标
主要结局
Oswestry Disability Index (ODI)
时间窗: Up to 12 months post-operatively
Change in Oswestry Disability Index (ODI) 100 point scale. The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools \[1\]. For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. If all 10 sections are completed the score is calculated by adding all scores for each statement, divided by 50 total possible points, and then multiplied by 100 for a percentage. Percentage scores are interpreted on a scale from 0-20% as minimal disability to 61-100% as crippled.
Comparison of Oswestry Disability Index (ODI)
时间窗: Up to 24 months post-operatively. (6 weeks, 3, 6, 12, and 24 months timepoints)
Compare ODI scores to assess the kinetics of improvement in the control (direct decompression) vs. treatment (indirect decompression) groups. The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools \[1\]. For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. If all 10 sections are completed the score is calculated by adding all scores for each statement, divided by 50 total possible points, and then multiplied by 100 for a percentage. Percentage scores are interpreted on a scale from 0-20% as minimal disability to 61-100% as crippled.
次要结局
- Complication Rate(Within 12 months and 24 months, post-operatively.)
- Radiographic Measurements - Lumbar Lordosis(Preoperative and 12-Month radiographs)
- Reoperation Rate(Within 12 months and 24 months, post-operatively.)
- Numeric Rated Scale (NRS)-Back and Leg pain(6- Weeks, 3-, 6-, 12-, and 24-Months.)
- Radiographic Measurements - Segmental Lordosis(Preoperative and 12-Month radiographs)
- Radiographic Measurements - Disc Space Height(Preoperative and 12-Month radiographs)