跳至主要内容
临床试验/NCT01868789
NCT01868789已完成不适用

In-Vivo Physiologic Weight-Bearing Assessment of Tarsal Instability: Three-Dimensional Cone-Beam Computed Tomography Analysis

Orthopedic Foot and Ankle Center, Ohio1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2013年5月1日最近更新:
适应症
干预措施

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
Change in Joint Motion Between Touch-down Bearing Navicular and Full-weight Bearing Navicular

研究概览

简要总结

The purpose of this study is to compare the average joint motion and joint axis orientation of the hindfoot bones between patients diagnosed with adult-acquired flatfoot disorder (AAFD) and a control group of patients without foot deformity, using weight-bearing CT technology.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

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

  • •Symptomatic group:
  • •Inclusion Criteria:
  • •adult patients (ages 18 -80 years old) diagnosed with Stage 2 AAFD

排除标准

  • •previous surgery
  • •tumor in the affected foot
  • •Control group:
  • •Inclusion Criteria:
  • •adult patients (ages 18 -80 years old) without foot deformity
  • •Exclusion Criteria:
  • •history of previous foot and ankle surgery
  • •foot deformity
  • •known foot and ankle pathology

研究组 & 干预措施

Weightbearing CT (AAFD group)

Experimental

Weightbearing CT scan of affected foot

干预措施: Weightbearing CT (Radiation)

Weightbearing CT (control group)

Active Comparator

Weightbearing CT scan of normal foot

干预措施: Weightbearing CT (Radiation)

结局指标

主要结局

Change in Joint Motion Between Touch-down Bearing Navicular and Full-weight Bearing Navicular

时间窗: 1 CT scan, one reading while touch-down bearing, one reading while full-weight bearing

Relative motion, which is the position of the full weightbearing (FWB, greater that 75-100% body weight) navicular in comparison to the touch down weightbearing (TDWB, 25-50% body weight) navicular position, will be determined by comparing the joint orientation across these two points on one CT scan. The difference between the two positions is reported below.

Change in Navicular Rotation Between Touch-down Bearing and Full-weight Bearing

时间窗: 1 CT scan, one reading while touch-down bearing, one reading while full-weight bearing

Relative motion across joint segments will be determined by comparing the joint orientation across two time points: touch-down bearing (TDWB, 25-50% body weight) and full-weight bearing (FWB, greater that 75-100% body weight) as measured on CT.

次要结局

未报告次要终点

研究者

发起方
Orthopedic Foot and Ankle Center, Ohio
申办方类型
Other
责任方
Sponsor

研究点 (1)

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