Study of Functional and Aesthetic Outcomes After Wassel IV Thumb Duplication Surgery in Pediatric Population, With a Follow-up of at Least One Year

April 17, 2024 updated by: University Hospital, Grenoble
The purpose of this study is to evaluate the functional and aesthetic outcomes in children with Wassel IV thumb duplication

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Wassel IV thumb duplication is a congenital hand anomaly characterized by the presence of two adjacent thumbs. This condition has significant functional and aesthetic implications.

Previous studies have highlighted the complexity of the surgical management of Wassel IV thumb duplication, underscoring the need for an individualized approach for each case. Early interventions are often recommended to optimize long-term functional and aesthetic outcomes.

The field of study for evaluating these outcomes focuses on the analysis of the medium and long-term consequences of surgical interventions in children with this malformation. Evaluation criteria may include hand functionality, thumb mobility, overall aesthetics, and other aspects relevant to the quality of life of the affected pediatric patients. This medium and long-term approach offers crucial insights for refining treatment protocols and improving the overall management of this condition.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients who have undergone surgical correction for Wassel IV thumb duplication and have been followed up for at least one year post-surgery. The study population includes patients from the CHU Grenoble Alpes and Clinique Val d'Ouest Lyon.

Description

Inclusion Criteria:

  • Confirmed diagnosis of Wassel IV thumb duplication
  • Pediatric patients aged between 1 and 18 years
  • Minimum of one year post-operative follow-up
  • Availability of radiographic, photographic, and medical data
  • Regular post-operative medical follow-up with the referring surgeon
  • Legal guardian and patient consent (non-opposition) to participate in the study

Exclusion Criteria:

  • Subjects under guardianship or deprived of liberty
  • Opposition from legal guardians or from the patient to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Wassel IV Thumb Duplication Cases
This group consists of pediatric patients who have undergone surgical correction for Wassel IV thumb duplication. All participants have had a minimum of one year post-operative follow-up. This cohort will be assessed for functional and aesthetic outcomes using the Japanese Society for Surgery of the Hand (JSSH) scoring method. This includes evaluating thumb mobility, functionality, global aesthetics, and other quality of life aspects for each patient using their contralateral healthy thumb as a control. Data will be collected on preoperative metacarpophalangeal angle, type of skin flap used, surgical reconstruction technique, immobilization method, postoperative complications, and patient satisfaction with surgery and daily pain levels.
Procedure: Wassel IV Thumb Duplication Surgery
This intervention involves the surgical correction of Wassel IV thumb duplication, which is a congenital hand anomaly. The study retrospectively evaluates the outcomes of various surgical techniques that have been employed to correct this condition, with a focus on functionality and aesthetics of the thumb post-surgery. Data collected post-intervention include preoperative metacarpophalangeal angle, type of skin flap, surgical reconstruction technique, immobilization method, and postoperative complications. Additionally, patient satisfaction and daily pain levels are assessed using standardized questionnaires. Each patient serves as their own control, with outcomes compared to their contralateral healthy thumb.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional and Aesthetic Outcomes
Time Frame: Up to one year post-surgery for the primary outcome measure time frame
Evaluation of functional and aesthetic outcomes using the Japanese Society for Surgery of the Hand (JSSH) scoring method. Functional outcomes include thumb mobility and function scored out of 10 points, and aesthetic outcomes include overall thumb appearance scored out of 14 points. The minimal and worst score is 0, the maximal and best score is 30.
Up to one year post-surgery for the primary outcome measure time frame

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Surgical Techniques
Time Frame: One year post-operative, to align with the follow-up period of the primary outcome measure.

Evaluate which surgical reconstruction techniques yield better functional and aesthetic outcomes.

Soft tissue reconstruction only or need for osteotomy.
One year post-operative, to align with the follow-up period of the primary outcome measure.
Efficacy of Skin Flap Types
Time Frame: One year post-operative, to align with the follow-up period of the primary outcome measure.

Assess the outcomes associated with different types of skin flaps used in the surgical correction.

Number of "racquet skin plasty" and number of "Dautel flap". The evaluation of skin flaps will be assessed by various measures: the circumference of the thumb in millimeters, the appearance of the scar by self-assessment (visual analogue scale), and the symmetry of the thumb by self-assessment (visual analogue scale). All these measures are integrated into the JSSH score.
One year post-operative, to align with the follow-up period of the primary outcome measure.
Immobilization Method Analysis
Time Frame: One year post-operative, to align with the follow-up period of the primary outcome measure.
Determine the effectiveness of various immobilization methods post-surgery. Plaster immobilization or splint, with or without wire.
One year post-operative, to align with the follow-up period of the primary outcome measure.
Preoperative Angle Decision Model
Time Frame: One year post-operative, to align with the follow-up period of the primary outcome measure.

Measurement of the preoperative metacarpophalangeal angle of the thumb to be reconstructed.

Develop a decision-making model for surgery based on the preoperative radiographic metacarpophalangeal angle.
One year post-operative, to align with the follow-up period of the primary outcome measure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 25, 2024

Primary Completion (Estimated)

May 6, 2024

Study Completion (Estimated)

May 15, 2024

Study Registration Dates

First Submitted

March 5, 2024

First Submitted That Met QC Criteria

April 17, 2024

First Posted (Actual)

April 22, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 38RC24.0012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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