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临床试验/NCT04284618
NCT04284618已完成不适用

Off Axis View Radiographs Assessing Hallux Valgus Interphalangeus in Hallux Valgus Deformity: A Comparison With the Traditional Anteroposterior Standing Radiographs

Dr.Gerhard Kaufmann1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年11月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
reliability of standardized Standing radiographs for defining hallux valugs interphalangeus

研究概览

简要总结

In hallux valgus deformity an additional deformity of the proximal phalangeal bone can be observed frequently as well. Due to a hyperpronation of the greater toe on standardized radiographs the deformity defining angles are likely to be underestimated. Therefore the investigators developed an off axis view radiograph for determining the real deformity. This study compares the standardized and the off axis view radiographs.

详细描述

Hallux valgus is a frequent deformity of the first ray of the foot with adduction and pronation of the greater toe at the first metatarsophalangeal joint and abduction of the first metatarsal at the first tarsometatarsal joint. Valgus deformity of the greater toe itself - so called "Hallux valgus interphalangeus (HVI)" - can be found regularly in hallux valgus deformities as well. Various osteotomies and soft tissue procedures to correct hallux valgus deformity have been proposed so far. While corrective osteotomies of the first metatarsal bone represent the main therapeutical option in hallux valgus correction, the need for additional phalangeal osteotomy of the greater toe (e.g., Akin osteotomy) is discussed controversial and remains a surgeon's decision to date. In this context, the decision to perform an additional Akin osteotomy depends on the radiographic measurement of the hallux valgus interphalangeus deformity.

The following radiographic angles to define HVI have been used most consistently in the literature so far: The hallux interphalangeal angle (HIA), the proximal to distal phalangeal articular angle (PDPAA), the proximal phalangeal articular angle (PPAA) or distal articular set angle (DASA), and the distal phalangeal articular angle (DPAA). To date, a hallux valgus interphalangeal angle of greater than 10 degrees serves as the most frequently used definition of HVI. However, the measurement of HIA is prone to error due to the irregular geometry of the distal phalanx. Therefore, the proximal to distal phalangeal articular angle might describe hallux valgus interphalangeus deformity more precisely and reliably. Furthermore, a significant hyperpronation of the phalangeal bone can be observed frequently in hallux valgus deformity. This phalangeal hyperpronation results in a non-orthogonal projection of the greater toe on preoperative films, which might be the cause for underestimation of HVI on standardized weightbearing radiographs.

The aim of this study is to investigate the reliability of radiological assessment of hallux valgus interphalangeus and to evaluate, if HVI can be defined more precisely using intraoperative anteroposterior "off axis view" radiographs additionally. The investigators hypothesize that (1) HVI is underestimated on pre-operative standardized anteroposterior radiographs compared to anteroposterior off axis views; (2) the Investigators hypothesize that PDPAA shows significantly less intra- and interobserver variance and is therefore more reliable than other angles (HIA, PPAA, DPAA) for measuring HVI; and (3) the investigators hypothesize, that the detected differences between weightbearing and off axis radiographs are a function of the severity of the deformity

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients who have undergone surgery for hallux valgus deformity by open or minimally invasive percutaneous hallux valgus correction at the Orthopedic and Foot Center Innsbruck between November 2018 and May 2019.

排除标准

  • Incomplete radiological data (preoperative and intraoperative radio-graphs)
  • Pregnancy
  • missing of written informed consent

结局指标

主要结局

reliability of standardized Standing radiographs for defining hallux valugs interphalangeus

时间窗: 12 weeks

Analysis of the reliability of radiological angles hallux valgus interphalangeus and evaluation, if Hallux valgus interphalangeus can be determined more precisely on off axis view radiographs. Evaluation is made with specific radiographic angles. The used angles are the following: hallux interphalangeal angle (HIA), the proximal to distal phalangeal articular angle (PDPAA), the proximal phalangeal articular angle (PPAA) or distal articular set angle (DASA), and the distal phalangeal articular angle (DPAA).

次要结局

  • correlation of hallux valgus interphalangeus angles with the severity of hallux valgus deformity(12 weeks)

研究者

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

Dr.Gerhard Kaufmann

Dr. Gerhard Kaufmann, Principal investigator and Head of the Orthopaedic and Foot Center Innsbruck

OFZ Innsbruck

研究点 (1)

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