Is Postoperative Bracing Necessary After Spine Surgery for Degenerative Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale and Oswestry Disability Index functional outcome
研究概览
简要总结
This study was started from Oct. 2015. This study aimed to evaluate the outcome of bracing following transforaminal lumbar interbody fusion (TLIF) in patients with degenerative lumbar spine diseases.
详细描述
The inclusion criteria were age older than 18 years and undergoing TLIF for degenerative lumbar disc disease, spinal stenosis, or spondylolisthesis. Those who had spinal fracture, spinal infection, spinal tumor, and a history of previous spinal surgery; and those who were lost to follow-up or failed to complete the questionnaires were excluded.
Patients eligible for the study were selected by an independent research assistant. The study was explained, and informed consent was obtained from patients before the surgery. Using a randomization sequence, the patients were assigned to the brace or no brace group. The attending surgeons and patients were blinded before the surgery.
Patients in the brace group were instructed to wear a rigid brace (Knight-Taylor [chairback] brace) full-time for 12 weeks, except when bathing or lying in bed. Patients in the no brace group were instructed to wear a soft corset for 2 weeks, after which it was weaned off. All patients started wearing the brace or corset during their first ambulation out of bed following drainage tube removal after the surgery.
The success of interbody fusion was evaluated by computed tomography (CT) at the 6-month postoperative follow-up using the Brantigan-Steffee-Fraser (BSF) classification6. Radiographic fusion (BSF-3) was defined as bone bridging at least half of the fusion area with at least the density originally achieved at surgery. Radiographic locked pseudarthrosis (BSF-2) was indicated by lucency visible in the middle of the cage with solid bone growing into the cage from each vertebral end plate. Radiographic pseudarthrosis (BSF-1) was indicated by collapse of the construct, loss of disk height, vertebral slip, broken screws, displacement of the cage, significant resorption of the bone graft, or lucency visible around the periphery of the graft or cage.
Perioperative complications, such as wound infection, epidural hematoma, intraoperative dural tear, nerve root damage, and implant dislodgement, were recorded, as were the reoperations and medically related complications within 6 months. The implant-related complications, such as screw loosening, cage migration, or broken screws, detected using plain radiograph at each follow-up and CT scan at the latest follow-up were also recorded. Pedicle screw loosening was defined as a radiolucent zone around the screw on a CT scan at the 6-month follow-up
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 (Investigator)
盲法说明
Patients eligible for the study were selected by an independent research assistant. The study was explained, and informed consent was obtained from patients before the surgery. Using a randomization sequence, the patients were assigned to the brace or no brace group.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients underwent TLIF for degenerative lumbar disc disease, spinal stenosis, or spondylolisthesis
排除标准
- •spinal fracture, spinal infection, spinal tumor, and a history of previous spinal surgery; and those who were lost to follow-up or failed to complete the questionnaires
研究组 & 干预措施
Brace group
After spinal surgery, patients in the brace group were instructed to wear a rigid brace (Knight-Taylor [chairback] brace) full-time for 12 weeks, except when bathing or lying in bed.
干预措施: Knight-Taylor [chairback] brace (Device)
No brace group
After spinal surgery, patients in the no brace group were instructed to wear a soft corset for 2 weeks, after which it was weaned off.
结局指标
主要结局
Visual Analogue Scale and Oswestry Disability Index functional outcome
时间窗: 6 months of postoperative follow-up
Visual Analogue Scale score was patient reported pain scale. The 0 score is no any pain. THe 10 score is the most pain ever. THe more the score the worsen the pain . The Oswestry Disability Index score is the most common used score for lumbar spine disability score. This score had only 10 questions, and all of the questions are related to pain and daily activity. 0 score is no any disability or pain. 100 score is the worst.
次要结局
- interbody fusion rate(postoperative 6 months follow-up)
- complication(postoperative 6 months follow-up)
- reoperation(postoperative 6 months follow-up)