跳至主要内容
临床试验/NCT02055495
NCT02055495已完成不适用

Prospective Comparison of Subtalar Arthroereisis To Lateral Column Lengthening for Painful Flatfeet

University of Utah1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
Kinematics motion analysis

研究概览

简要总结

There is no consensus on the surgical treatment of unremitting, painful flatfeet in children. Subtalar arthroereisis has gained notoriety although there is a paucity of literature on its biomechanical effects. The goal of the investigators was to compare a group treated with subtalar arthroereisis with another group undergoing lateral column calcaneal lengthening. The investigators hypothesis was that the results of arthroereisis would be equivalent to the more established method of calcaneal lengthening.

详细描述

The purpose of this prospective, non-randomized study was to evaluate two different surgical treatments for symptomatic planovalgus feet: lateral column lengthening osteotomy and subtalar arthroereisis. The goal of the investigators was to compare the outcomes of these two surgeries and determine whether both treatments resulted in clinical improvement. This was accomplished through the use of pre- and post-operative kinematics, pedobarography, radiographic measurements, and validated outcome measures. The investigators were particularly interested in analyzing the kinematic changes to quantify the changes in the foot mobility and alignment during ambulation, as it has not been previously studied to our knowledge. The investigators hypothesis was that both procedures would show significant improvement and be equivalent in their results.

A prospective trial was conducted. The investigators enrolled fifteen patients (mean age 12.8y, 24 feet) with painful, planovalgus feet refractory to conservative treatment. Seven patients (13 feet) were enrolled in the arthroereisis group, and eight patients (11 feet) were enrolled in the calcaneal lengthening group. Though not specifically excluded, none of the enrolled patients had an underlying neuromuscular diagnosis. Kinematic motion analysis was performed on each patient prior to surgery and at one year of follow-up. Pedobarometry studies, radiographs, and validated outcome questionnaires (Oxford Ankle-Foot Questionnaire for Children) were also performed to evaluate the outcomes of both groups.

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
7 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Planovalgus foot deformity
  • Patient normally ambulates without use of assistive devices
  • Patient is between the ages of 7 and 17 at the initial evaluation

排除标准

  • Hip flexion contractures greater than 15 deg.
  • Knee flexion contractures greater than 10 deg.
  • Ankle dorsiflexion less than 0 deg. (plantarflexion contracture)
  • Taking medication which effects motor control
  • Inability to follow instructions to perform study

结局指标

主要结局

Kinematics motion analysis

时间窗: 1 year

The change in hindfoot angle, degree of hindfoot mobility both pre- and postoperatively, degree of ankle motion both pre- and postoperatively, and amount of flexion occurring between the forefoot and hindfoot both pre- and postoperatively.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bruce MacWilliams

Associate Professor, Director, Movement Analysis Laboratory

University of Utah

研究点 (1)

Loading locations...

相似试验