- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04284618
Off Axis View Radiographs Assessing Hallux Valgus Interphalangeus in Hallux Valgus Deformity
Off Axis View Radiographs Assessing Hallux Valgus Interphalangeus in Hallux Valgus Deformity: A Comparison With the Traditional Anteroposterior Standing Radiographs
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Tirol
-
Innsbruck, Tirol, Austria, 6020
- Gerhard Kaufmann
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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).
|
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).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: Foot Ankle Int 2002 Feb;23(2):96.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1100/2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hallux Valgus
-
Arthrex GmbHTerminated
-
Catherine Vandepitte, M.D.Pacira Pharmaceuticals, IncCompleted
-
Asklepieion Voulas General HospitalMaria Tileli; Chryssoula StaikouUnknown
-
Dr.Gerhard KaufmannMedical University InnsbruckCompletedHallux Valgus and BunionAustria
-
Chinese University of Hong KongCompletedHallux Valgus | Hallux Valgus and BunionHong Kong
-
Hospital Mutua de TerrassaUnknownHallux Valgus and Bunion (Disorder)Spain
-
Assiut UniversityNot yet recruitingHallux Valgus and Bunion
-
Cali Pharmaceuticals LLCCompletedHallux Valgus and BunionUnited States
-
Fundación Universidad Católica de Valencia San...RecruitingHallux Valgus and BunionSpain
-
China Medical University HospitalUnknownHallux Valgus and Bunion (Disorder)Taiwan
Clinical Trials on assessment of standardized and off axis view radiographs
-
National Cheng-Kung University HospitalCompleted
-
AmgenUniversity of AarhusCompleted
-
RWTH Aachen UniversityRecruitingCOPD | Sympathetic Nervous System Diseases | Catecholamine; OverproductionGermany
-
First Affiliated Hospital of Zhejiang UniversityRecruitingCytarabine+Thiotepa + Fludarabine + Busulfan | T Cell Acute Lymphoblastic Leukemia/Lymphoblastic LymphomaChina
-
Ohio State UniversityCompletedPost-operative DeliriumUnited States
-
Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingPain | Malignant Neoplasm | Urinary Urgency | Bladder SpasmUnited States
-
Hospices Civils de LyonRecruiting
-
University Hospital, GenevaRecruitingParkinson DiseaseSwitzerland
-
Assistance Publique - Hôpitaux de ParisRecruitingHypohidrotic Ectodermal DysplasiaFrance
-
University Children's Hospital BaselRecruitingPulmonary DysfunctionSwitzerland