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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06377670
Enrollment
30
Registered
2024-04-22
Start date
2024-04-25
Completion date
2024-05-15
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wassel IV Thumb Duplication

Keywords

functional outcomes, aesthetic outcomes, pediatric surgery, thumb reconstruction

Brief summary

The purpose of this study is to evaluate the functional and aesthetic outcomes in children with Wassel IV thumb duplication

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.

Interventions

PROCEDUREWassel 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.

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Functional and Aesthetic OutcomesUp to one year post-surgery for the primary outcome measure time frameEvaluation 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.

Secondary

MeasureTime frameDescription
Comparison of Surgical TechniquesOne 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.
Efficacy of Skin Flap TypesOne 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.
Immobilization Method AnalysisOne 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.
Preoperative Angle Decision ModelOne 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.

Contacts

Primary ContactEmeline Bourgeois
ebourgeois@chu-grenoble.fr0476767575
Backup ContactAida Mandzo
amandzo@chu-grenoble.fr04 76 76 68 16

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026