Mini-invasive Lumbar Arthrodesis in Ambulatory: Pilot Study "ALAMBU"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- To evaluate the feasibility of mini-invasive lumbar arthrodesis on an ambulatory in patients with degenerative lumbar disease who have failed with conventional treatment.
研究概览
简要总结
Degenerative lumbar pathologies are characterised by functional impairment and the occurrence of severe chronic pain and disability Arthrodesis of the lumbar spine is a common surgery for the treatment of degenerative lumbar pathologies. It is commonly performed during a hospital stay that can vary from 3 to 7 days. The development of mini-invasive techniques and the development of the Improved Rehabilitation after Surgery programmes, has considerably reduced the hospital stay of the patients. It is possible that in the future mini-invasive lumbar arthrodesis will be performed on an ambulatory as a standard procedure, but its safety, efficacy and patient satisfaction must be proven and validated.
详细描述
Degenerative lumbar disease (DLD) is a condition of increasing frequency, affecting millions of patients worldwide. They are characterised by functional impairment and the occurrence of severe chronic pain and disability.
Arthrodesis of the lumbar spine is a common surgery for the treatment of DLD. It is commonly performed during a hospital stay that can vary from 3 to 7 days. The advent of mini-invasive techniques and the development of Improved Rehabilitation after Surgery program has made it possible to considerably reduce the duration of hospitalization of patients with a high rate of satisfaction, a reduction in costs and without increasing morbidity. In spinal surgery, decompression procedures such as discectomy and lumbar recalibration are frequently performed on an ambulatory. The first American studies with a low level of evidence on the management of mini-invasive lumbar arthrodesis are beginning to appear. It is quite possible that in the future this type of procedure will be carried out on an ambulatory as a standard procedure, but its safety, efficacy and patient satisfaction must be proven and validated. In the United States, 23-hour hospitalizations are considered as ambulatory procedures, whereas in France, ambulatory is qualified as such when the patient is admitted and discharged in the same day.
The study population was patients who had failed medical treatment (analgesics and rehabilitation) for more than three months and who required a mono-segmental arthrodesis procedure for the management of their lumbar-radiculalgia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Age between 18 and 75 years
- •Patients affiliated to a social security system.
- •Informed, dated and signed consent
- •ASA 1 or 2
- •Patient compliant and adhering to protocol visits
- •Indication for a 1-level mini-invasive lumbar arthrodesis performed by anterior or posterior approach
- •Failure of conservative treatment for more than 3 months
排除标准
- •History of lumbar arthrodesis
- •Active neoplasia
- •History of osteoporotic fractures of the spine
- •Arthrodesis superior to 1 level
- •Intolerance or contraindication to morphine treatments
- •Respiratory insufficiency
- •Preoperative anticoagulant treatment
- •Contraindication to the ambulatory care: patient living alone at home, or at a distance from the establishment, and thus requiring a follow-up care and rehabilitation hospitalization
- •Patient with a body mass index of greater than 40 kg/m².
- •Patient with a fever (>38°C)
- •Suspected or known allergy or intolerance to the materials used and requiring a combination of different metals.
- •Patient with a contraindication to the material used or for whom the use of the implant could interfere with their anatomical structures or expected physiological function.
- •Pregnant or breastfeeding women
- •Patient participating to an ongoing study that may interfere with the present study
- •Patient under legal protection
结局指标
主要结局
To evaluate the feasibility of mini-invasive lumbar arthrodesis on an ambulatory in patients with degenerative lumbar disease who have failed with conventional treatment.
时间窗: within 24 hours after surgery
Percentage of patients with same-day discharge
次要结局
- Evaluate lumbar pain(at 1-year visit)
- Evaluate early morbidity(within 1st week)
- Evaluate the short-term morbidity(within 1st month)
- Evaluate the mid-term morbidity(within 1st year)
- Evaluate radicular pain(at 1-year visit)
- Evaluate lumbar and radicular pain(before the 1-month visit)
- Evaluate the safety of ambulatory lumbar arthrodesis(through study completion, an average of 1 year)
- Evaluate patient satisfaction with the procedure(at 1-year visit)
- Evaluate the patients' quality of life(at 1-year visit)
- Evaluate radiological parameters(at 1-year visit)