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

• ClinicalTrials.gov Identifier: NCT03843177
• Recruitment Status: Completed
• First Posted: February 15, 2019
• Last Update Posted: February 19, 2019
• Sponsor: Chinese University of Hong Kong
• Information provided by (Responsible Party): Him Shun KEI, Chinese University of Hong Kong

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
Ingrown Toe Nail; Flat Foot; Hallux Abductovalgus; Hallux Limitus	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: March 14, 2018
• Actual Primary Completion Date: April 27, 2018
• Actual Study Completion Date: April 27, 2018

Groups and Cohorts

Group/Cohort	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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: throughout the study, within 1 year after ingrown toenails for the ingrown toenail group ]
   • Radiological measurement for hallux abducto valgus
   • Normal: <15º
4. Active maximum dorsiflexion of the first metatarsophalangeal joint on weight bearing [ Time Frame: throughout the study, within 1 year after ingrown toenails for the ingrown toenail group ]
   Clinical measurement with goniometer for hallux limitus

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

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

Hong Kong

Prince of Wales Hospital

Hong Kong, Hong Kong

Sponsors and Collaborators

Chinese University of Hong Kong

More Information

• Responsible Party: Him Shun KEI, MSc Student, Chinese University of Hong Kong
• ClinicalTrials.gov Identifier: NCT03843177
• Other Study ID Numbers: 2017.637
• First Posted: February 15, 2019
• Last Update Posted: February 19, 2019
• Last Verified: February 2019

Individual Participant Data (IPD) Sharing Statement:

• 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:

Flatfoot; Hallux Limitus; Hallux Rigidus; Hallux Valgus; Nails, Ingrown; Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Nail Diseases; Skin Diseases; Joint Diseases; Foot Injuries; Leg Injuries; Wounds and Injuries