Utility of High-resolution Ultrasound to Evaluate Dorsal Osteophyte

Fundación Universidad Católica de Valencia San Vicente Mártir

Status: Completed

Conditions: Exostosis

Treatments: Procedure: Cut fingernail; Procedure: Exostectomy

Study type: Observational

Funder types: Other

Identifiers

NCT06266208

UCV/2021-2022/201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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)

Trial design

50 participants in 2 patient groups

Group A (non-operated):

Description:

This group will consist of patients with clinical and radiological diagnosis of painful claw nail with wide nail curvature and presence of dorsal osteophyte on radiograph. They will not have received previous surgery for this condition. They will be followed up conservatively for 1 month, with baseline measurements of nail curvature, nail thickness, osteophyte height and nail-phalange distance. This group will allow correlating the osteophyte height with the degree of nail deformity without surgical intervention.

Treatment:

Procedure: Cut fingernail

Group B (operated):

Description:

This group will include patients who meet the same inclusion criteria as Group A. They will receive surgical treatment for claw nail by partial matrixectomy and removal of the osteophyte. They will be followed up postoperatively for 1 month, with baseline and evolutionary measurements. This group will allow to evaluate the effect of surgery on nail anatomy and symptomatology. At the end of the study, baseline and evolutionary measurements will be compared between groups to analyze the effect of surgical treatment.

Treatment:

Procedure: Exostectomy