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
- 1
- 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
研究组 & 干预措施
Dorsal Cheilectomy no Amniotic Membrane Tissue Implantation
Dorsal cheilectomy is a surgery for hallux rigidus(degenerative arthritis and stiffness due to bone spurs that affect the joint at the base of the big toe). No amniotic membrane will be used for this group.
干预措施: Dorsal Cheilectomy without Amniotic Membrane Tissue Implantation (Procedure)
Dorsal Cheilectomy-Amniotic Membrane Tissue Implantation
Dorsal cheilectomy procedure with the addition of the amniotic membrane. Amniotic membrane represents a biologic therapy that has the ability to actively regulate myrofibroblast formation and activity within the joint space and surgical site
干预措施: Dorsal Cheilectomy with Amniotic Membrane Tissue Implantation (Procedure)
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