Fourth Generation Percutaneous Transverse Osteotomies for Hallux Valgus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 483
- 试验地点
- 1
- 主要终点
- Manchester-Oxford Foot Questionnaire (MOXFQ)
研究概览
简要总结
The goal of this observational study is to learn if percutaneous transverse osteotomies for hallux valgus deformity are safe and effective. The main questions it aims to answer are:
- What is the change in clinical patient reported outcome measures after minimally invasive bunion surgery
- What severity of bunion deformity can be corrected with minimally invasive surgery
- What factors may lead to recurrence of bunion deformity
- What is the rate of complications following bunion deformity surgery
Researchers will retrospectively review a research registry containing prospectively collected clinical and radiographic deformity data collected as part of routine care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of hallux valgus that has failed conservative treatment
排除标准
- •Degenerative changes of first MTPJ
- •Previous hallux valgus deformity correction surgery
结局指标
主要结局
Manchester-Oxford Foot Questionnaire (MOXFQ)
时间窗: Patients completed the MOXFQ at 6,12 and 24 months following surgery. Patients outside of these time points were asked to complete scores at their final follow up.
A validated patient reported outcome measure for assessment of function in hallux valgus. The Manchester Oxford Foot Questionnaire (MOXFQ) consists of 3 domains (walking and standing, social interaction \[based on the patient's self-consciousness regarding their feet/shoes as well as the overall impact on social, recreational, work, and other everyday activities\], and pain), with the score in each domain ranging from 0 (best possible score) to 100 (worst possible score). An overall summary "index" score can also be calculated. The minimal clinically important difference (MCID) has been shown to be 16, 12, and 24 for the walking and standing, pain, and social interaction domains, respectively.
次要结局
- Complication Data(Clinical notes were reviewed at final follow up (minimum 12 months post surgery) following surgery to assess for any complications)
- EuroQol 5D Health Related Quality of Life (EQ-5D)(Patients completed the EQ5D at 6,12 and 24 months following surgery. Patients outside of these time points were asked to complete scores at their final follow up(minimum 12 months following surgery).)
- Radiographic Deformity Correction(Specified timepoints during study (6weeks, 6months, final follow up (minimum 12 months following surgery))
- Visual Analogue Scale for Pain (VAS Pain)(Patients completed the VAS Pain at 6,12 and 24 months following surgery. Patients outside of these time points were asked to complete scores at their final follow up(minimum 12 months following surgery).)
研究者
Thomas Lewis
Principal Investigator
Orthopaedic and Arthritis Specialist Centre