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

Sponsor
Dr.Gerhard Kaufmann (Other)
Overall Status
Completed
CT.gov ID
NCT04284618
Collaborator
Medical University Innsbruck (Other)
60
1
9.6
6.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: assessment of standardized and off axis view radiographs

Detailed Description

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

Study Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Off Axis View Radiographs Assessing Hallux Valgus Interphalangeus in Hallux Valgus Deformity: A Comparison With the Traditional Anteroposterior Standing Radiographs
Actual Study Start Date :
Nov 10, 2018
Actual Primary Completion Date :
May 31, 2019
Actual Study Completion Date :
Aug 30, 2019

Arms and Interventions

Arm Intervention/Treatment
assessment of radiographic angles on standardized films

On Standing standardized radiographs of the foot the most common angles for describing a hallux valgus interphalangeus deformity are measured. The measured angles are the following: 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).

Diagnostic Test: assessment of standardized and off axis view radiographs
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.

assessment of radiographic angles on off axis view films

On off axis view radiographs of the foot the most common angles for describing a hallux valgus interphalangeus deformity are measured. The measured angles are the following: 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).

Diagnostic Test: assessment of standardized and off axis view radiographs
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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gerhard Kaufmann Innsbruck Tirol Austria 6020

Sponsors and Collaborators

  • Dr.Gerhard Kaufmann
  • Medical University Innsbruck

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dr.Gerhard Kaufmann, Dr. Gerhard Kaufmann, Principal investigator and Head of the Orthopaedic and Foot Center Innsbruck, OFZ Innsbruck
ClinicalTrials.gov Identifier:
NCT04284618
Other Study ID Numbers:
  • 1100/2019
First Posted:
Feb 26, 2020
Last Update Posted:
Feb 26, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 26, 2020