Association of Ingrown Toenails With Flat Foot, Hallux Abducto Valgus and Hallux Limitus

NCT03843177 | Completed

• 1 other identifier: 2017.637
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This study will have implications for any healthcare professionals who routinely manage ingrown toenails. Although different conservative and surgical treatment have been suggested, the recurrent rate is still high ranging from 20% to 30%. The objective of this study was to investigate the association of ingrown toenail (IGTN) with flat foot, hallux abducto valgus (HAV) and hallux limitus (HL), and to provide directions for addressing biomechanical risk factors in the prevention of recurrent ingrown toenails. This was the first study to investigate the association of IGTN with flat foot, and the first study in Chinese community to investigate the association of IGTN with HAV or HL. Participants with ingrown toenails (IGTN) were recruited to this study and compared with control participants with no history of ingrown toenails. The inclusion criteria for the IGTN group were: (1) history of ingrown toenails on hallux within 1 year and (2) dorso-plantar standing view of foot x-ray taken or to be taken. The exclusion criteria for the IGTN group were: (1) paediatrics (Age\<18), (2) pincer nails / fungal nails, (3) prior existence of osteoarticular surgery in the foot, (4) severe trauma that changes foot morphology, (5) uncontrolled systemic disease, (6) pre-existing neurological diseases and (7) lower limb paralysis or paresis. The inclusion criterion for the control group was dorso-plantar standing view of foot x-ray taken or to be taken. The exclusion criteria for the control group were: (1) all the exclusion criteria of IGTN group, (2) history of IGTN in his or her lifetime and (3) flatfoot / first metatarsophalangeal joint pathology as the chief complaint. The symptomatic foot (or the more symptomatic foot in the case of bilateral involvement) in the IGTN group was examined. The left or right foot of the control group was randomly selected such that the ratio of the left or the right foot in the IGTN and control group was the same. Their foot posture index-6 components, Staheli's index, radiological hallux valgus angle and active maximum dorsiflexion of the first metatarsophalangeal joint on weight-bearing were measured and compared. For dependent variables with significant correlation, a one-way multivariate analysis of variance (MANOVA) was carried out to determine if there was a significant difference on the combined dependent variables. For dependent variables without significant correlation, separate independent sample t-tests / welch t-tests were performed.

Conditions

Ingrown Toe Nail; Flat Foot; Hallux Abductovalgus; Hallux Limitus

Outcome Measures

Primary Outcomes (4)

• Foot Posture Index-6 components

  * Clinical assessment for flat foot * Normal: 0 to +5 * Pronated: +5 to +9 ; Highly pronated: +10 or above * Supinated: -1 to -4; Highly supinated: -5 to -12

  throughout the study, within 1 year after ingrown toenails for the ingrown toenail group

• Staheli's Index

  * It provides a measurement of flat foot on footprint. * The Staheli's index increases as the foot becomes more pronated and is closer to zero as the foot becomes more supinated.

  throughout the study, within 1 year after ingrown toenails for the ingrown toenail group

• radiological Hallux Valgus Angle

  * Radiological measurement for hallux abducto valgus * Normal: \<15º

  throughout the study, within 1 year after ingrown toenails for the ingrown toenail group

• Active maximum dorsiflexion of the first metatarsophalangeal joint on weight bearing

  Clinical measurement with goniometer for hallux limitus

  throughout the study, within 1 year after ingrown toenails for the ingrown toenail group

Study Arms (2)

Ingrown toenails

Other: No intervention

Control

Interventions

No intervention OTHER

No intervention will be performed. Only assessment will be done.

Ingrown toenails

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients attending the Orthopaedic out-patient clinic at Prince of Wales Hospital in Hong Kong

You may qualify if:

• history of ingrown toenails on hallux within 1 year
• dorso-plantar standing view of foot x-ray taken or to be taken

You may not qualify if:

• paediatrics (Age\<18)
• pincer nails / fungal nails
• prior existence of osteoarticular surgery in the foot
• severe trauma that changes foot morphology
• uncontrolled systemic disease
• pre-existing neurological diseases
• lower limb paralysis or paresis
• \- dorso-plantar standing view of foot x-ray taken or to be taken
• history of IGTN in his or her lifetime
• flatfoot / first metatarsophalangeal joint pathology as the chief complaint

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Nails, Ingrown; Flatfoot; Hallux Valgus; Hallux Limitus

Condition Hierarchy (Ancestors)

Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Joint Diseases; Foot Injuries; Leg Injuries; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Student

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 15, 2019
• Study Start: March 14, 2018
• Primary Completion: April 27, 2018
• Study Completion: April 27, 2018
• Last Updated: February 19, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)