Amniotic Membrane as an Adjunct Treatment for Hallux Rigidus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- American Orthopedic Foot and Ankle Society (AOFAS) score
研究概览
简要总结
The purpose of this study is to determine whether patients undergoing a dorsal cheilectomy procedure with implementation of amniotic membrane tissue results in improved clinical and functional outcomes compared to a standard dorsal cheilectomy procedure.
Specific Aim 1:
To compare American Orthopedic Foot and Ankle Society (AOFAS) scores between patients undergoing dorsal cheilectomy to patients undergoing dorsal cheilectomy with implantation of amniotic membrane tissue.
Hypothesis 1: Clinical and functional outcomes, as measured by the AOFAS , in the patients undergoing dorsal cheilectomy with implantation of amniotic membrane tissue will be superior to those without.
Specific Aim 2:
To compare range of motion between patients undergoing dorsal cheilectomy to patients undergoing dorsal cheilectomy with implantation of amniotic membrane tissue.
Hypothesis 2: Patient to undergo dorsal cheilectomy and implantation of amniotic membrane tissue will demonstrate less postoperative stiffness as measured from the pre-and postoperative radiographs.
Specific Aim 3:
To compare Foot Function Index (FFI) scores between patients undergoing dorsal cheilectomy to patients undergoing dorsal cheilectomy with implantation of amniotic membrane tissue.
Hypothesis 3: Clinical and functional outcomes, as measured by the FFI, the patients undergoing dorsal cheilectomy with implantation of amniotic membrane tissue will be superior to those without.
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 (Participant)
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 presented with an isolated diagnosis of type II hallux rigidus who are candidates for operative management with dorsal cheilectomy.
- •Patients over the age of 18 able to consent to participate
- •The subject is psychosocially, mentally, and physically able to understand and comply with the requirements of the study
排除标准
- •< 18 years of age
- •Patients that use ambulatory assistive devices
- •Patients with systemic inflammtory arthritis
- •Patient undergoing revision surgery for hallux rigidus to the ipsilateral extremity
- •Patients with significant arthritis requiring alternative surgery other than dorsal cheilectomy
结局指标
主要结局
American Orthopedic Foot and Ankle Society (AOFAS) score
时间窗: 6 Months
次要结局
未报告次要终点