Effect of Lateral Soft Tissue Release on Patient-Reported Outcomes and Hallux Valgus Angle Correction in Chevron Osteotomy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Hallux valgus alpha angle correction
研究概览
简要总结
The goal of this clinical trial is to determine if performing a lateral soft tissue release during a Chevron osteotomy (or Akin osteotomy when appropriate) for bunions leads to better correction without added complications in 200 patients over the age of 18 years old with the capacity to consent and mild to moderate bunions that are determined to benefit from Chevron osteotomies by one of the IRB approved study physicians. The main questions it aims to answer are:
How does the addition of a lateral soft tissue release (LSTR) in a Chevron osteotomy bunion surgery affect hallux valgus alpha angle (HVA) correction? How does the addition of an LSTR in a Chevron osteotomy bunion surgery affect intermetatarsal angle (IMA) degrees of correction? Researchers will compare Chevron osteotomy bunion surgeries with and without LSTR to see if LSTRs lead to better correction without added complications.
Participants will:
- Be randomized to a control group where they receive a typical Chevron osteotomy bunion surgery or to the experimental group where they receive a Chevron osteotomy bunion surgery with an LSTR.
- Complete surveys preoperatively and at 3, 6, and 12 months after surgery.
- Receive routine x-rays pre and postoperatively to compare hallux valgus angle (HVA).
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
- None
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
- •Over the age of 18 years old
- •Have mild to moderate bunions that are determined to benefit from Chevron osteotomies
排除标准
- •Under the age of 18
- •Connective tissue disease
- •Juvenile bunions
- •Severe bunions
- •Revision surgery
研究组 & 干预措施
Chevron osteotomy bunion surgery with LSTR
Participants randomized to this group will receive a Chevron osteotomy bunion surgery and a lateral soft tissue release.
干预措施: Chevron osteotomy bunion surgery with lateral soft tissue release (Procedure)
Chevron osteotomy bunion surgery without LSTR
Participants randomized to this group will receive a standard Chevron osteotomy bunion surgery.
结局指标
主要结局
Hallux valgus alpha angle correction
时间窗: Pre-surgery, 6 weeks post surgery
次要结局
- Intermetasarsal angle (IMA) degrees of correction(3 months, 6 months, and 12 months post surgery)
- Recurrence of hallux valgus deformity(3 months, 6 months, and 12 months post surgery)
- Complications following surgery(3 months, 6 months, and 12 months post surgery)
研究者
Kevin Varner
Chairman of the Department of Orthopedics
The Methodist Hospital Research Institute