Allograft Knee Meniscal Transplantation in the Treatment of Osteoarthritis of the Metatarsophalangeal (MTP) Joint of the Great Toe
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Allograft Stability
研究概览
简要总结
Using the concept of an implant acting as a spacer and stabilizer, the proposed study will evaluate the use of allograft knee meniscus in the treatment of MTP joint osteoarthritis of the great toe.
详细描述
A variety of surgical procedures have been developed for the treatment of MTP joint osteoarthritis of the great toe. Using the concept of an implant acting as a spacer and stabilizer, the proposed study will evaluate the use of allograft knee meniscus in the treatment of MTP joint osteoarthritis of the great toe. Patients will be evaluated for pain and range of motion at 3-months, 6-months, 1-year, 2-years, 3-years, 4-years, and 5-years postoperatively or until allograft failure. Stability of the allograft will be evaluated by the surgeon at these time points per radiographic imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •symptomatic of stage 3 osteoarthritis of the great toe
- •symptoms recalcitrant to nonoperative management as determined clinically by the principal investigator
排除标准
- •diabetes mellitus
- •kidney insufficiency
- •oa in the adjacent joints
- •malignancy with in the past 10 yrs
- •minors (< 18 yrs of age)
- •pregnant women and fetus
- •mentally disabled or cognitively impaired individuals
结局指标
主要结局
Allograft Stability
时间窗: 5-years postoperative
Evaluation of the MTP joint space as determined by radiographic imaging. Count of participants maintaining adequate spacing and alignment as evaluated by the surgeon.
次要结局
- Range of Motion Plantarflexion(3-months postoperative)
- Pain(3-months postoperative)
- Range of Motion Dorsiflexion(3-months postoperative)
研究者
Paul Fortin, MD
Orthopedic Surgeon
William Beaumont Hospitals