Utility of High-resolution Ultrasound to Evaluate Dorsal Osteophyte

NCT06266208 | Completed

• 1 other identifier: UCV/2021-2022/201
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 4

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.

Conditions

Exostosis

Keywords

Dorsal osteophyte; Ultrasound; Nail curvature; Nail-phalanx distance

Outcome Measures

Primary Outcomes (1)

• 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.

  Pre-surgery, 2 months, 6 months.

Secondary Outcomes (3)

• Nail Curvature Index

  Pre-surgery, 1 months

• Thickness of the nail plate

  Pre-surgery, 1 months

• Dorsal Osteophyte Height

  Pre-surgery, 1 months

Study Arms (2)

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.

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.

Procedure: Exostectomy

Interventions

Exostectomy PROCEDURE

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.

Group B (operated):

Cut fingernail PROCEDURE

Patients diagnosed with dorsal osteophyte and experiencing pain underwent nail cut fingernail

Group A (non-operated):

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fundación Universidad Católica de Valencia San Vicente Mártir: lead

Study Sites (4)

Enieto podologos

Logroño, La Rioja, 26003, Spain

Location

Centro podológico Valencia

Valencia, València, 46001, Spain

Location

Clinicas UCV

Valencia, València, 46001, Spain

Location

Clinica Pasito a pasito

Valencia, 46008, Spain

Location

Related Publications (3)

• Vuilleumier J. [Status and problems of the physicians' assistant]. Rev Med Suisse Romande. 1979 Jul;99(7):479-81. No abstract available. French.

  PMID: 40297 RESULT

• 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.

  PMID: 26300982 RESULT

• 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.

  PMID: 30156888 RESULT

MeSH Terms

Conditions

Exostoses

Condition Hierarchy (Ancestors)

Hyperostosis; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Emma Guillem-Escamez

  Doctorate School UCV

  PRINCIPAL INVESTIGATOR

• JAVIER FERRER TORREGROSA, Dr.

  Podiatry Department, Faculty of Medicine and Health Sciences, UCV

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 20, 2024
• Study Start: March 20, 2024
• Primary Completion: April 15, 2024
• Study Completion: July 2, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4)