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Functional Outcome Assessment After (Calcaneal) Trauma Surgey (FACTS)

2015年10月13日 更新者:Maastricht University Medical Center
To include patient after traumatic (calcaneal) fractures for this study. They can be included to analyze gait with the OFM foot model, a non invasis model. Patient will be invited to the movement laboratory of the MUMC. Markers will be detached with dubble sided tape on anatomical points. After that gait will be recorded with infra-red camera's and an animation model will be formed. With this model further analysis can be made to range of motion between different segement of the foot. These results will be compared with patient with an arthrodesis, healthy subjects, futher questionnaires, physical examination and radiographic findings will be correlated.

研究概览

地位

完全的

干预/治疗

详细说明

All subjects are asked to come to the movement laboratory of Maastricht University Medical Centre on one individual day. Before gait analyses the following characteristics were measured; height, weight, BMI, knee and ankle width (measured between the two condyles of the knee and the measured between the two malleoli of the ankle) and leg length . All measurements are performed by researchers who was trained in the examination of the foot. At least one static trial was performed with all 42 markers, with the subjects in stance phase in an anatomic neutral position. After calibrating the markers and calculating the subject-specific joint axes in the static trial, 6 markers were removed, according to the OFM protocol. After that the subjects were asked to walk barefoot in normal speed after a number of practice trials. For this speed at least 8 proper recordings were made during walking. The healthy subjects were also asked to walk in slow speed and 8 proper recordings were made during this slow-speed walking. One whole step was considered complete from heel landing (initial contact) to toe-off. A force plate was used to determine the heel-strike and toe-off phase during walking. Corrections in the axes of the knee and ankle were made if necessary and tiles were saved for further data output.

研究类型

观察性的

注册 (实际的)

20

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 85年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

概率样本

研究人群

healthy subjects and patients after foot and ankle trauma fracture surgery

描述

Inclusion Criteria:

  • patients with foot and ankle fractures

Exclusion Criteria:

  • concomitant surgery for fractures of contra lateral leg/ankle or pre-existent abnormalities of the lower extremities, neurotrauma, spinal or neurological injury, pathologic fractures and people dependent in activities of daily living

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Fratures
patient with foot and ankle fractures and surgery with ORIF
surgery for foot and ankle fractures
healthy subjects
patients without foot and ankle fracture s

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Gait in Patients After foot and ankle fractures range of motion
大体时间:6 months after surgery
To measure range of motion in the foot and ankle with the OFM (range of motion in degrees) and compare between patients with foot and ankle fractures after surgery and healthy subjects range of motion between forefoot and hindfoot, hindfoot and tibia in 3 planes representing flexion/extension, abduction/adduction, inversion/eversion
6 months after surgery

次要结果测量

结果测量
措施说明
大体时间
To find correlations between gait, questionnaires, radiographic findings and physical examination
大体时间:6 months after surgery
correlations between gait (OFM, see above) AOFAS score (0-100_ Foot and ankle disability index FADI 0-100 VAS pain score (0-10) Short Form 36 SF 36 physical examination range of motion in the subtalar joint (inversion/eversion) in degrees en in the ankle (flexion/extension) degrees radiographic findings (in calcaneal patients, bohlers angle, gissane's angle) in general congruency of the joint with step-off and gap
6 months after surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年10月1日

初级完成 (实际的)

2015年3月1日

研究完成 (实际的)

2015年3月1日

研究注册日期

首次提交

2015年10月5日

首先提交符合 QC 标准的

2015年10月13日

首次发布 (估计)

2015年10月15日

研究记录更新

最后更新发布 (估计)

2015年10月15日

上次提交的符合 QC 标准的更新

2015年10月13日

最后验证

2010年12月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • NL34131.068.10/ MEC 10-3-072

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

创伤的临床试验

ORIF的临床试验

3
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