Finnish Trial on Practices of Anterior Cervical Decompression and Fusion (FACADE): A Protocol for a Prospective Randomized Non-inferiority Trial Comparing Outpatient vs. Inpatient Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Change from baseline Neck Disability Index at 6 months after operation
研究概览
简要总结
FACADE is a prospective, randomized, controlled, parallel group non-inferiority trial comparing the traditional hospital surveillance (inpatient, patients staying in the hospital for 1-3 nights after surgery) to outpatient care (discharge on the day of the surgery, usually within 6-8 hours after procedure) in patients who have undergone anterior cervical decompression and fusion (ACDF) procedure.
详细描述
To determine whether early discharge (outpatient care) is noninferior to inpatient care, the investigators will randomize 104 patients to these two groups and follow them for 6 months using the Neck Disability Index (NDI) as the primary outcome. The investigators expect that early discharge is not significantly worse (inferior) than the current care in terms of change in NDI. Noninferiority will be declared if the mean improvement for outpatient care is no worse than the mean improvement for inpatient care, within statistical variability, by a margin of 17.3%. The investigators hypothesize that a shorter hospital stay results in more rapid return to normal daily activities, shorter duration of sick leave and decreased secondary costs to health care system. Secondary outcomes in the study are arm pain and neck pain using the Numeric Rating Scale, operative success (Odom's criteria), patient's satisfaction to treatment, general quality of life (EQ-5D-5L), work ability score (WAS), sickness absence days, return to previous leisure activities, and complications.
Patients who are eligible for the trial, but are not willing to undergo randomization, will be asked to be included in a simultaneous, pragmatic follow-up cohort.
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)
入排标准
- 年龄范围
- 18 Years 至 62 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cervical radiculopathy syndrome (CRS) unresponsive to non-operative treatment for at least six weeks or with severe progressive signs and symptoms of nerve root compression during conservative treatment of shorter duration.
- •CRS is defined as pain, paresis or paresthesia in corresponding nerve root distribution areas of C5, C6, C7 or C
- •Nerve root stenosis determined by magnetic resonance imaging at treatment level correlating to CRS/symptoms
- •Neck Disability Index score ≥30 out of 100
- •Age between 18 to 62 years
- •No previous cervical operations
- •Currently employed
- •No co-morbidities causing a need for a sick leave
- •Provision of informed consent from the participant
- •No contraindication for randomization in postoperative check (see below)
排除标准
- •MRI finding inconsistent with patient's symptoms
- •Diagnosed osteoporosis or permanent use of oral corticosteroids
- •ACDF operation requiring plate or cage fixation with screws
- •Active malignancy
- •American Society of Anesthesiologists Physical Status Classification system (ASA) 4 and 5 patients (seriously ill patients)
- •Abundant use of alcohol, drugs or narcotics
- •No possibility to be accompanied by an adult person over the first postoperative night after the surgery
- •Insufficient Finnish language skills
- •Distance to the closest hospital emergency more than 60 min
结局指标
主要结局
Change from baseline Neck Disability Index at 6 months after operation
时间窗: Before and up to 6 months after operation
Neck disability Index scale score ranges from 0 to 100%. Score 0 indicates no disability as score 100% indicates worst possible disability.
次要结局
- Change from baseline Numeric rating scale on neck pain at six months after operation(Before and up to 6 months after operation)
- The duration of sick leave(Before and after operation)
- Change from baseline Numeric rating scale on arm pain at six months after operation(Before and up to 6 months after operation)
- Rate of returning to previous leisure activities after operation(Before and up to 6 months after operation)
- Change from baseline Work Ability Score (WAS) at six months after operation(Before and up to 6 months after operation)
研究者
Kimmo Lonnrot
Principal Investigator
Helsinki University Central Hospital