Wrist Fractures Management With Arthroscopic Assistance Under Walant - Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Failure percentage
研究概览
简要总结
Wrist articular fractures are more difficult to treat and rehabilitation takes longer. Furthermore, these joint fractures are frequently accompanied by ligament lesions of the carpal bones.
For these reasons, it is strongly recommended to check the interior of the wrist joint. This check can be done with wrist arthroscopy. Therefore, fracture reduction can be improved, "step of stairs" can be eliminated under arthroscopic control and ligament rupture of carpal bones can be treated.
WALANT anesthesia (Wide Awake Local Anesthesia No Tourniquet) designates a new local anesthesia technique. This technique which allows to maintain the arm or fingers mobility offers several significant advantages:
- Greater precision of the surgical procedure.
- A reduction in discomfort, risks and related adverse effects to anesthesia.
- Faster recovery.
WALANT technique is very comfortable for patient and fits perfectly with principles of Enhanced Recovery in Surgery.
In this context, this study is based on the hypothesis that it is possible to combine arthroscopy and the WALANT anesthesia technique for reducing wrist fractures
详细描述
Wrist fractures are common. Most often, when speaking about wrist fracture, this means distal radius fracture, the radius being one of the two forearm bones and most often affected in cases of fracture. A fracture is articular when the fracture line "goes down" in the joint.
These fractures are more difficult to treat and rehabilitation takes longer because it is necessary to ensure that joint surface is perfectly reduced, this means that there are no "stair steps" in the joint. Furthermore, these joint fractures are frequently accompanied by ligament lesions of the carpal bones.
For all these reasons, it is strongly recommended to check the interior of the wrist joint. This check can be done with wrist arthroscopy. Arthroscopy not only allows for a complete assessment of lesions but also to treat most of them. Therefore, fracture reduction can be improved, "step of stairs" can be eliminated under arthroscopic control and a ligament rupture of carpal bones can be treated.
WALANT anesthesia (Wide Awake Local Anesthesia No Tourniquet) designates a new local anesthesia technique which is based on administration, in association with local anesthetic (lidocaine), of a medicine (epinephrine) which limits bleeding and allows to dispense with a tourniquet. The local anesthetic administration allows to maintain the arm or fingers mobility, while having complete anesthesia. This technique offers several significant advantages:
- Greater precision of the surgical procedure. In fact, bleeding limitation and the patient's state of cooperation allow a greater surgical precision.
- A reduction in discomfort, risks and related adverse effects to anesthesia.
- Faster recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient, male or female, aged ≥ 18 and < 70 years
- •Patient with a displaced articular fracture of the distal radius (unilateral wrist fracture)
- •Patient treated on ambulatory way
- •Patient affiliated to or beneficiary of a social security system
- •French speaking patient, having signed informed consent
排除标准
- •Patient with previous infection or wrist bone surgery
- •Patient with multiple fractures or with bilateral wrist fractures
- •Patient with associated fracture with the wrist fracture
- •Patient with "pathological" bone
- •Protected patient: adult under guardianship, curatorship or other protection legal, deprived of liberty by judicial or administrative decision
- •Patient hospitalized without consent
结局指标
主要结局
Failure percentage
时间窗: Day 1
A failure is defined by the impossibility of achieving the surgery under WALANT anesthesia. Practically, this translates either to stopping the procedure, either by intra-operative sedation (Protoxide nitrogen, deep hypnosis, general anesthesia) in emergency
次要结局
- Functional characteristics of the wrist(Day 7 and 30)
- Complications(Day 1 to Day 30)
- Pain assessment(Day 1, 7 and 30)
- Patient experience(Day 1)
- Wrist mobility(Day 7 and 30)