Early 2 Weeks Versus Delayed 6 Weeks Post-Operative Weight-Bearing in Total Ankle Replacement
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- osseointegration
研究概览
简要总结
The Investigators hypothesize that an early 2 week post-operative protocol will have no difference in the successful osseointegration and stability of the total ankle replacement as compared to a delayed 6 week post-operative protocol. The importance of the research is to allow patients who receive a total ankle replacement to bear weight 4 weeks earlier than the current protocol with no negative effect on the osseointegration and stability of the ankle replacement.
详细描述
The study will be conducted using two groups. The first group will be a retrospective review of charts of 35 patients who received a total ankle replacement porous prosthesis by an orthopedic surgeon at the University of Oklahoma Health Sciences Center. This group was received a delayed 6 week post-operative weight-bearing protocol.
The second group will be prospective and include patients who will receive the same total ankle replacement porous prosthesis but will be assigned to early 2 weeks post-operative weight-bearing protocol.The retrospective and prospective groups will be age and gender matched. A Wright Medical Infinity Total Ankle Replacement System will be used for both groups.
Both groups will be assessed at 1 year and 2 years post-operative. This assessment will take place during the post-operative care period and will be conducted as part of their post-operative care by the operating physician.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who have had a total ankle replacement with the Principal Investigator from the initiation of his clinical practice from September 2015 to September
- •Had delayed weight-bearing. Patients whose age and gender match the retrospective delayed weight-bearing group.
- •Retrospective/Prospective
排除标准
- •Patients who have had Total Ankle Replacement with subsequent development of suture wound infection.
- •Patients who have had Total Ankle Replacement with subsequent development of deep infection requiring revision.
- •Patient who have had Total Ankle Replacement with subsequent development of Peri-prosthetic fractures during surgery or post-op.
结局指标
主要结局
osseointegration
时间窗: time of surgery through 2 years
a Chi Square Test will take place during the post-operative care period and will be conducted as part of their post-operative care by the operating physician.
次要结局
- stability of implant(time of surgery through 2 years)