ExostosisNCT06266208
Utility of High-resolution Ultrasound to Evaluate Dorsal Osteophyte
An observational study of Exostosis, run by Fundación Universidad Católica de Valencia San Vicente Mártir at 4 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Exostosis
- What is being tested?
- Exostectomy and Cut fingernail
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 4 sitesSpain
- Study dates
- 20 Mar 2024to 2 Jul 2024
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Clinical and radiological diagnosis of claw nail in at least one toe.
- Pain associated with claw nail for at least 1 month.
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
Spain4 sites
Enieto podologos
Logroño, La Rioja, 26003
Centro podológico Valencia
Valencia, València, 46001
Clinicas UCV
Valencia, València, 46001
Clinica Pasito a pasito
Valencia, 46008
About this study
Official title: Utility of High-resolution Ultrasound to Evaluate Dorsal Osteophyte Associated With Onychocryptosis: Correlation With Radiology.
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.
Read more
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.
Read the 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.
- Conditions
- Exostosis
- Being tested
- Exostectomy, Cut fingernail
- Keywords
- Dorsal osteophyte, Ultrasound, Nail curvature, Nail-phalanx distance
- Medical subject headings
- Exostoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExostectomyProcedure or surgery
Patients diagnosed with dorsal osteophyte and experiencing pain were advised to proceed with osteophyte removal surgery during their initial visit.The surgical procedure, following protocol occurred during the second visit and involved the following steps: a 2-4 mm incision using a Beaver-64-MIS scalpel on the distal surface wall of the toe, parallel to its longitudinal axis, followed by careful osteophyte drilling; precise delineation of the osteophyte contour using a blunt elevator to prevent nailbed damage; resection executed through medial and lateral movements facilitated by a mini-Shannon drill; and finally, pressure application with a surgical spoon to extract the bone paste resulting from the drilling process.
Cut fingernailProcedure or surgery
Patients diagnosed with dorsal osteophyte and experiencing pain underwent nail cut fingernail
| Study group | Role | What they receive |
|---|---|---|
| Group A (non-operated): | 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. Receives: Procedure: Cut fingernail | |
| Group B (operated): | 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. Receives: Procedure: Exostectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nail-phalange distance
The measurement of the minimum distance between the dorsal cortex of the distal phalanx and the ventral aspect of the nail of the first toe will be done using lateral radiographs and longitudinal ultrasounds. Lateral radiographs capture toe images from a side angle to determine the spatial relationship between the two points, with measurements expressed in millimeters. Longitudinal ultrasounds provide real-time images to visualize this relationship, with the ultrasound transducer placed along the toe. Both methods offer vital insights into toe anatomy for medical purposes like assessing deformities, tracking injuries, or planning surgeries.
Measured: Pre-surgery, 2 months, 6 months.
Secondary outcomes (3)
Nail Curvature Index
The maximum height and width of the nail plate in lateral view will be measured. The curvature index will be calculated as (nail height / nail width) x 100.
Measured: Pre-surgery, 1 months
Thickness of the nail plate
The maximum anteroposterior thickness of the nail plate in its medial part will be determined.
Measured: Pre-surgery, 1 months
Dorsal Osteophyte Height
The height of the subungual exostosis will be measured on lateral radiographs of the distal phalanx.
Measured: Pre-surgery, 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start20 Mar 2024
- Primary completion15 Apr 2024
- Study completion2 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ExostosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Fundación Universidad Católica de Valencia San Vicente Mártir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emma Guillem-Escamez, Principal investigator, Doctorate School UCVJAVIER FERRER TORREGROSA, Dr., Study director, Podiatry Department, Faculty of Medicine and Health Sciences, UCV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266208
- Sponsor's protocol ID
- UCV/2021-2022/201
- Status last verified
- Jul 2024
- First submitted
- 25 Jan 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vuilleumier J. [Status and problems of the physicians' assistant]. Rev Med Suisse Romande. 1979 Jul;99(7):479-81. No abstract available. French.
PubMed 40297Sano 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.
PubMed 26300982Perez-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.
PubMed 30156888
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of High-resolution Ultrasound to Evaluate Dorsal Osteophyte Associated With Onychocryptosis: Correlation With Radiology.
- ClinicalTrials.gov ID
- NCT06266208
- Acronym / sponsor ID
- UCV/2021-2022/201
- Conditions
- Exostosis
- Keywords
- Dorsal osteophyte, Ultrasound, Nail curvature, Nail-phalanx distance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fundación Universidad Católica de Valencia San Vicente MártirUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 2 Jul 2024 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (non-operated): | – | Procedure: Cut fingernailThis 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. |
| Group B (operated): | – | Procedure: ExostectomyThis 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Clinical and radiological diagnosis of claw nail in at least one toe.
- Pain associated with claw nail for at least 1 month.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExostectomyPatients diagnosed with dorsal osteophyte and experiencing pain were advised to proceed with osteophyte removal surgery during their initial visit.The surgical procedure, following protocol occurred during the second visit and involved the following steps: a 2-4 mm incision using a Beaver-64-MIS scalpel on the distal surface wall of the toe, parallel to its longitudinal axis, followed by careful osteophyte drilling; precise delineation of the osteophyte contour using a blunt elevator to prevent nailbed damage; resection executed through medial and lateral movements facilitated by a mini-Shannon drill; and finally, pressure application with a surgical spoon to extract the bone paste resulting from the drilling process. | Procedure or surgery | Group B (operated): |
| Cut fingernailPatients diagnosed with dorsal osteophyte and experiencing pain underwent nail cut fingernail | Procedure or surgery | Group A (non-operated): |
Primary outcome
Nail-phalange distance
Time frame: Pre-surgery, 2 months, 6 months.
The measurement of the minimum distance between the dorsal cortex of the distal phalanx and the ventral aspect of the nail of the first toe will be done using lateral radiographs and longitudinal ultrasounds. Lateral radiographs capture toe images from a side angle to determine the spatial relationship between the two points, with measurements expressed in millimeters. Longitudinal ultrasounds provide real-time images to visualize this relationship, with the ultrasound transducer placed along the toe. Both methods offer vital insights into toe anatomy for medical purposes like assessing deformities, tracking injuries, or planning surgeries.
3 secondary outcomes
Nail Curvature Index
Time frame: Pre-surgery, 1 months
Thickness of the nail plate
Time frame: Pre-surgery, 1 months
Dorsal Osteophyte Height
Time frame: Pre-surgery, 1 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Results publication: PubMed 40297Vuilleumier J. [Status and problems of the physicians' assistant]. Rev Med Suisse Romande. 1979 Jul;99(7):479-81. No abstract available. French.
- Results publication: PubMed 26300982Sano 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.
- Results publication: PubMed 30156888Perez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma Guillem-Escamez principal investigator
Doctorate School UCV
JAVIER FERRER TORREGROSA, Dr. study director
Podiatry Department, Faculty of Medicine and Health Sciences, UCV
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exostosis, run by Fundación Universidad Católica de Valencia San Vicente Mártir at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nail-phalange distance (time frame: Pre-surgery, 2 months, 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06266208, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.