Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06266208
Status:
COMPLETED
Last Update Posted:
2024-07-11
First Post:
2024-01-25
Brief Title:
Utility of High-resolution Ultrasound to Evaluate Dorsal Osteophyte
Sponsor:
Fundación Universidad Católica de Valencia San Vicente Mártir
Organization:
Fundación Universidad Católica de Valencia San Vicente Mártir
Study Overview
Official Title:
Utility of High-resolution Ultrasound to Evaluate Dorsal Osteophyte Associated With Onychocryptosis Correlation With Radiology
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None