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

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Completed
CT.gov ID
NCT03843177
Collaborator
(none)
41
1
1.4
28.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Detailed Description

Precautions were taken to ensure consistency in measurement. To standardize the bisection techniques in measuring radiological hallux valgus angle, this study followed the recommendation from the American Orthopaedic Foot & Ankle Society. The longitudinal axis of the first metatarsal and that of the first proximal phalanx were formed respectively by 2 reference points marked on each of the two bones. The reference points on the first proximal phalanx were 1/2 to 1 cm proximal or distal to the articular surface while the reference points on the first metatarsal were 1 to 2 cm proximal or distal to the articular surface.

The active maximum dorsiflexion of the first metatarsophalangeal joint was measured with goniometer on weight-bearing. The bisection was carried out under a weight-bearing condition to avoid error due to soft-tissue movement when participants changed from a non weight-bearing position to a weight-bearing position.

Study Design

Study Type:
Observational
Actual Enrollment :
41 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Association of Ingrown Toenails With Flat Foot, Hallux Abducto Valgus and Hallux Limitus
Actual Study Start Date :
Mar 14, 2018
Actual Primary Completion Date :
Apr 27, 2018
Actual Study Completion Date :
Apr 27, 2018

Arms and Interventions

Arm Intervention/Treatment
Ingrown toenails

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

Control

Outcome Measures

Primary Outcome Measures

  1. Foot Posture Index-6 components [throughout the study, within 1 year after ingrown toenails for the ingrown toenail group]

    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

  2. Staheli's Index [throughout the study, within 1 year after ingrown toenails for the ingrown toenail group]

    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.

  3. radiological Hallux Valgus Angle [throughout the study, within 1 year after ingrown toenails for the ingrown toenail group]

    Radiological measurement for hallux abducto valgus Normal: <15ยบ

  4. Active maximum dorsiflexion of the first metatarsophalangeal joint on weight bearing [throughout the study, within 1 year after ingrown toenails for the ingrown toenail group]

    Clinical measurement with goniometer for hallux limitus

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion criteria for the IGTN group:
  • history of ingrown toenails on hallux within 1 year

  • dorso-plantar standing view of foot x-ray taken or to be taken

Exclusion criteria for the IGTN group:
  • 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

Inclusion criterion for the control group:
  • dorso-plantar standing view of foot x-ray taken or to be taken
Exclusion criteria for the control group:
  • all the exclusion criteria of IGTN group

  • history of IGTN in his or her lifetime

  • flatfoot / first metatarsophalangeal joint pathology as the chief complaint

Contacts and Locations

Locations

Site City State Country Postal Code
1 Prince of Wales Hospital Hong Kong Hong Kong

Sponsors and Collaborators

  • Chinese University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Him Shun KEI, MSc Student, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT03843177
Other Study ID Numbers:
  • 2017.637
First Posted:
Feb 15, 2019
Last Update Posted:
Feb 19, 2019
Last Verified:
Feb 1, 2019
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 19, 2019