A Randomized, Prospective, Controlled Trial for Lateral Column Lengthening in Adult Acquired Flatfoot Using Biofoam Porous Metal Compared With Allograft
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The degree of correction as measured by talonavicular coverage angle, which is used to quantify the degree of deformity. Degree of correction is defined as the difference between the preoperative and postoperative talonavicular coverage angle.
研究概览
简要总结
The purpose of this study is to compare the clinical and radiographic outcomes of a randomized, consecutive series of adult patients, with an acquired flatfoot, treated with a lateral column lengthening using an allograft bone wedge versus a titanium porous metal implant (Biofoam, Wright Medical).
Null hypothesis: At six months postoperatively, there is no difference in the degree of correction as measured by the talonavicular coverage angle between patients randomized to allograft and Biofoam.
Alternative hypothesis: At six months postoperatively, the degree of correction as measured by the talonavicular coverage angle will be less in patients randomized to allograft than the degree of correction in patients randomized to Biofoam.
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
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 25-75
- •Unresponsive to conservative treatment
- •Patient with acquired flatfoot deformity, who is a candidate for lateral column lengthening (Stage IIB) = (greater than > 40% uncoverage of talar head by navicular on standing AP radiograph)
排除标准
- •Less than 25 years of age and greater than 75 years
- •Pre-existing infection
- •Peripheral neuropathy
- •Charcot arthropathy
- •Peripheral vascular disease
- •Rhematoid Arthritis (RA) or inflammatory arthropathy
- •Metal allergy or sensitivity to metal
研究组 & 干预措施
Biofoam
干预措施: Biofoam (Device)
Iliac Crest Allograft with locked plate
干预措施: Iliac Crest Allograft with locked plate (Other)
结局指标
主要结局
The degree of correction as measured by talonavicular coverage angle, which is used to quantify the degree of deformity. Degree of correction is defined as the difference between the preoperative and postoperative talonavicular coverage angle.
时间窗: 2 weeks, 6 weeks, 12 weeks, and 6 months
次要结局
- American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score(2 weeks, 6 weeks, 3 months, and 6 months)
- Foot Function Index (FFI) Score(2 weeks, 6 weeks, 3 months, and 6 months)
- Pain Visual Analog Scale (VAS)(2 weeks, 6 weeks, 3 months, and 6 months)
- Implant failure(2 weeks, 6 weeks, 3 months, and 6 months)