Clinical trial NCT06266208: Utility of High-resolution Ultrasound to Evaluate Dorsal Osteophyte
Official title: Utility of High-resolution Ultrasound to Evaluate Dorsal Osteophyte Associated With Onychocryptosis: Correlation With Radiology.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exostosis
Keywords: Dorsal osteophyte
Ultrasound
Nail curvature
Nail-phalanx distance
Lead sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population will be adult men and women diagnosed with painful claw nails. It is estimated to recruit 115 patients who meet the selection criteria from the podiatric consultation. The expected mean age is 45-55 years, a range consistent with the typical prevalence of this deformity. There will probably be a higher proportion of women given the greater predisposition of this sex. Participants should have nail curvatures and toenail pain of more than 1 month of evolution. Other concomitant pathologies and factors that could confound the association between osteophyte and nail curvature will be excluded.

Brief summary: This study will evaluate the usefulness of ultrasonography in detecting dorsal osteophytes associated with claw nails compared to radiographs. The hypothesis will be that the larger the size of the osteophyte, the greater the nail curvature.

Nail curvature and osteophyte height will be measured in patients with clamp nails. Nail-phalange distance will also be measured with radiography and ultrasonography.

The investigators to find a positive correlation between nail curvature and osteophyte height. Furthermore, a strong agreement is expected between both imaging techniques to measure nail-phalange distance.

Ultrasonography could constitute a safe and effective alternative to radiology for detecting dorsal osteophytes in claw nails, especially in mild cases, follow-ups or young patients.

Detailed description: Main objective:

The investigators aim to explore the possible relationship between the degree of dorsal curvature of the nail plate and the height of the dorsal osteophyte in subungual exostosis patients before and after surgery.

Secondary objectives:

The investigators will compare the distance between the nail surface and the dorsal cortex of the distal phalanx using plain radiographs and high-resolution ultrasonography.

Materials and Methods:

This is an Interventional study patients experiencing nail pain due to clamp nails will be enrolled. Two groups will be formed depending on the presence of exostosis or not. Patients diagnosed with subungual exostosis who consent to surgery will undergo preoperative measurements. After surgery, these patients will be re-evaluated to assess the restoration of normal nail curvature values, as well as the height of the exostosis or its distance from the nail.

Measurements:

Nail curvature will be assessed using the nail curvature index, and nail height and thickness will also be measured. Dorsal osteophyte height will be assessed on radiographs and ultrasound images before and after treatment.

Expected results:

The investigators anticipate a positive correlation between dorsal osteophyte height and nail curvature. In addition, they do not expect significant differences in nail-phalange distance measurements between radiography and ultrasonography.

Conclusions:

High-resolution ultrasonography may emerge as an alternative diagnostic tool to detect subungual exostosis without exposure to ionizing radiation.

Eligibility criteria: Inclusion Criteria:

* Clinical and radiological diagnosis of claw nail in at least one toe.
* Pain associated with claw nail for at least 1 month.

Exclusion Criteria:

* Pregnancy or breastfeeding
* Previous trauma or surgery on the affected toe
* Systemic diseases such as diabetes mellitus, renal insufficiency, rheumatoid arthritis
* Current or previous treatment for ingrown toenail within the last year
* Severe digital deformities (e.g. Hallux Valgus, hammer toe, claw toe)

Primary outcomes:
measure: Nail-phalange distance
timeFrame: Pre-surgery, 2 months, 6 months.
Secondary outcomes:
measure: Nail Curvature Index
timeFrame: Pre-surgery, 1 months
measure: Thickness of the nail plate
timeFrame: Pre-surgery, 1 months
measure: Dorsal Osteophyte Height
timeFrame: Pre-surgery, 1 months
Other outcomes:
Locations:
city: Logroño
country: Spain
facility: Enieto podologos
state: La Rioja
city: Valencia
country: Spain
facility: Centro podológico Valencia
state: València
city: Valencia
country: Spain
facility: Clinicas UCV
state: València
city: Valencia
country: Spain
facility: Clinica Pasito a pasito
Study officials:
affiliation: Doctorate School UCV
name: Emma Guillem-Escamez
role: PRINCIPAL_INVESTIGATOR
affiliation: Podiatry Department, Faculty of Medicine and Health Sciences, UCV
name: JAVIER FERRER TORREGROSA, Dr.
role: STUDY_DIRECTOR
References:
citation: Vuilleumier J. [Status and problems of the physicians' assistant]. Rev Med Suisse Romande. 1979 Jul;99(7):479-81. No abstract available. French.
citation: Sano H, Shionoya K, Ogawa R. Foot loading is different in people with and without pincer nails: a case control study. J Foot Ankle Res. 2015 Aug 19;8:43. doi: 10.1186/s13047-015-0100-y. eCollection 2015.
citation: Perez-Palma L, Manzanares-Cespedes MC, de Veciana EG. Subungual Exostosis Systematic Review and Meta-Analysis. J Am Podiatr Med Assoc. 2018 Jul;108(4):320-333. doi: 10.7547/17-102.