Internal Brace Augmented Anterior Inferior Tibiofibular Ligament Repair and Its Post-operative Effects on Syndesmotic Volumes: A Prospective, Single-blinded, Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Syndesmotic Volumetric Ratio
研究概览
简要总结
Over the course of a year from the start of the research study, twenty subjects will be randomized evenly into one of two groups after an informed consent is obtained: a traditional tight rope fixation group or a tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace group. Postoperative reduction was assessed by 3D volumetric ratios and measured by weight-bearing CT at 6-weeks and 3-months post-operation. Patient Reported Outcomes (PROs) were collected preoperatively, and at 6-weeks, 3-months, 6-months, and 1-year post-operation and included the Foot and Ankle Outcome Score and the 36-Item Short Form Survey Instrument (RAND-36) . Differences in volumetric ratios and PROs were evaluated between groups and time periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients who fit the study injury list
排除标准
- •prior surgery on ankle
- •bi-lateral surgery
- •recent participation in another study within the last 90days
研究组 & 干预措施
Tight Rope Fixation
干预措施: Tight rope fixation (Device)
tight rope fixation w/ AITFL repair augmentation with an internal brace
干预措施: Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace (Device)
结局指标
主要结局
Syndesmotic Volumetric Ratio
时间窗: 3 months post-operative volume
use of weight-bearing CT scan to measure; In order to compare the 3D syndesmotic volume between groups, the volume ratio was calculated for each patient by dividing the syndesmotic volume of the operative ankle by the syndesmotic volume of the contralateral uninjured ankle
Syndesmotic Volumetric Ratio
时间窗: 6-Weeks Post-op
use of weight-bearing CT scan to measure; In order to compare the 3D syndesmotic volume between groups, the volume ratio was calculated for each patient by dividing the syndesmotic volume of the operative ankle by the syndesmotic volume of the contralateral uninjured ankle
次要结局
- 36-Item Short Form Survey Instrument (RAND-36) Summary Scores(6 weeks post-operative)
- RAND-36 Summary Scores(1 year post-operative)
- Foot and Ankle Outcome Score (FAOS)(1 year post-operative)
- RAND-36 Summary Scores(3 months post-operative)
- RAND-36 Summary Scores(6 months post-operative)
- Foot and Ankle Outcome Score (FAOS)(6 weeks post-operative)
- Foot and Ankle Outcome Score (FAOS)(3 months post-operative)
- Foot and Ankle Outcome Score (FAOS)(6 months post-operative)
研究者
Blake E. Moore, MD
Principal Investigator
Vann Virginia Center for Orthopaedics dba Atlantic Orthopaedic Specialists