Skip to main content
OpenTrials
Completed

NCT Number: NCT04284618

Off Axis View Radiographs Assessing Hallux Valgus Interphalangeus in Hallux Valgus Deformity

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gerhard Kaufmann

Innsbruck, Tyrol, 6020, Austria

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

assessment of standardized and off axis view radiographs

Diagnostic Test

Radiographic assessment of hallux valgus interphalangeus angles is performed on preoperative standing anteroposterior and on off axis view radiographs. These radiographs are taken by equalizing the hyperpronation of the greater toe.

Primary outcomes

  1. reliability of standardized Standing radiographs for defining hallux valugs interphalangeus

    Time frame: 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).

Secondary outcomes

  1. correlation of hallux valgus interphalangeus angles with the severity of hallux valgus deformity

    Time frame: 12 weeks

    analysis of hallux valgus severity and ist influence on weightbearing and off axis radiographs by the use of 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).

Sponsors and collaborators

Lead sponsor

Dr.Gerhard Kaufmann

Other

Collaborators

  • Medical University Innsbruck

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 26, 2020
Registry last updated
Feb 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.