NCT04284618

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
Last Updated

February 26, 2020

Status Verified

February 1, 2020

Enrollment Period

7 months

First QC Date

February 19, 2020

Last Update Submit

February 22, 2020

Conditions

Hallux Valgus InterphalangeusHallux Valgus

Outcome Measures

Primary Outcomes (1)

  • reliability of standardized Standing radiographs for defining hallux valugs interphalangeus

    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).

    12 weeks

Secondary Outcomes (1)

  • correlation of hallux valgus interphalangeus angles with the severity of hallux valgus deformity

    12 weeks

Study Arms (2)

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

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

Interventions

assessment of standardized and off axis view radiographsDIAGNOSTIC_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.

assessment of radiographic angles on off axis view filmsassessment of radiographic angles on standardized films

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

a retrospective cohort of 60 patients is assessed

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gerhard Kaufmann

Innsbruck, Tyrol, 6020, Austria

Location

Related Publications (7)

  • Kaufmann G, Sinz S, Giesinger JM, Braito M, Biedermann R, Dammerer D. Loss of Correction After Chevron Osteotomy for Hallux Valgus as a Function of Preoperative Deformity. Foot Ankle Int. 2019 Mar;40(3):287-296. doi: 10.1177/1071100718807699. Epub 2018 Oct 31.

    PMID: 30379084BACKGROUND

  • Partio N, Maenpaa H, Huttunen T, Haapasalo H, Laine HJ, Mattila VM. Incidence of hallux valgus primary surgical treatment. Finnish nationwide data from 1997 to 2014. Foot Ankle Surg. 2019 Dec;25(6):761-765. doi: 10.1016/j.fas.2018.10.001. Epub 2018 Oct 17.

    PMID: 31796164BACKGROUND

  • Deenik A, van Mameren H, de Visser E, de Waal Malefijt M, Draijer F, de Bie R. Equivalent correction in scarf and chevron osteotomy in moderate and severe hallux valgus: a randomized controlled trial. Foot Ankle Int. 2008 Dec;29(12):1209-15. doi: 10.3113/FAI.2008.1209.

    PMID: 19138485BACKGROUND

  • Klugarova J, Hood V, Bath-Hextall F, Klugar M, Mareckova J, Kelnarova Z. Effectiveness of surgery for adults with hallux valgus deformity: a systematic review. JBI Database System Rev Implement Rep. 2017 Jun;15(6):1671-1710. doi: 10.11124/JBISRIR-2017-003422.

    PMID: 28628523BACKGROUND

  • Thordarson DB, Rudicel SA, Ebramzadeh E, Gill LH. Outcome study of hallux valgus surgery--an AOFAS multi-center study. Foot Ankle Int. 2001 Dec;22(12):956-9. doi: 10.1177/107110070102201205.

    PMID: 11783920BACKGROUND

  • Kaufmann G, Hofmann M, Braito M, Ulmer H, Brunner A, Dammerer D. Need for concomitant Akin osteotomy in patients undergoing Chevron osteotomy can be determined preoperatively: a retrospective comparative study of 859 cases. J Orthop Surg Res. 2019 Aug 28;14(1):277. doi: 10.1186/s13018-019-1319-2.

    PMID: 31455364BACKGROUND

  • Kaufmann G, Hofmann M, Ulmer H, Putzer D, Hofer P, Dammerer D. Outcomes after scarf osteotomy with and without Akin osteotomy a retrospective comparative study. J Orthop Surg Res. 2019 Jun 26;14(1):193. doi: 10.1186/s13018-019-1241-7.

    PMID: 31242910BACKGROUND

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot DeformitiesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Gerhard Kaufmann, Principal investigator and Head of the Orthopaedic and Foot Center Innsbruck

Study Record Dates

First Submitted

February 19, 2020

First Posted

February 26, 2020

Study Start

November 10, 2018

Primary Completion

May 31, 2019

Study Completion

August 30, 2019

Last Updated

February 26, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)