Minimally Invasive Versus Open Scarf Osteotomy for Hallux Valgus Correction: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Hallux valgus angle postoperative
研究概览
简要总结
The purpose of this study was to compare a minimally invasive scarf technique and the well-established open scarf technique for correction of hallux valgus deformity.
详细描述
Hallux valgus surgery is a common procedure being the open scarf osteotomy, one of the most studied techniques for correction of the hallux valgus. It is widely reported its capacity to reduce the angle of the first metatarso-phalangeal joint.
Minimally invasive scarf (MIS) technique has been designed to decrease the soft tissue damage and postoperative pain. This procedure does not require ischemia, being able to do under local anesthesia and sedation. This technique is more suitable for outpatient surgery.
There is a lack of studies comparing both techniques, and our purpose is to do a prospective comparative study among the two approaches of the scarf osteotomy: open vs MIS.
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 (Outcomes Assessor)
盲法说明
The outcomes assessor will not know the technique
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergo hallux valgus surgery
排除标准
- •Intermetatarsal angle >20º
- •Previous hallux valgus surgery
- •Metatarsalgia of the lesser rays that requires an osteotomy during the surgical procedure
- •1st cuneometatarsal instability
- •Infection
- •Vascular ischemia
- •Neuropathy
研究组 & 干预措施
Open Scarf Osteotomy
This group of patients will undergo surgery performing an open scarf osteotomy
干预措施: Open Scarf Osteotomy (Procedure)
Minimally invasive scarf Osteotomy
This group of patients will undergo surgery performing a Minimally invasive scarf osteotomy
干预措施: Minimally invasive scarf Osteotomy (Procedure)
结局指标
主要结局
Hallux valgus angle postoperative
时间窗: 1 year - 2 years
The angle among the first metatarsal and the first phalanx
次要结局
- Intermetatarsal 1-2 angle(1 year - 2 years)
- Surgery duration(Measurement during the surgery)
- First metatarso-phalangeal range of movement(1 year - 2 years)
- Irradiation(Measurement during the surgery)
研究者
josep torrent
Josep Torrent m.d.
Hospital Mutua de Terrassa