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

NCT06377670 | Not Yet Recruiting

• 1 other identifier: 38RC24.0012
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Wassel IV Thumb Duplication

Keywords

functional outcomes; aesthetic outcomes; pediatric surgery; thumb reconstruction

Outcome Measures

Primary Outcomes (1)

• Functional and Aesthetic Outcomes

  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 Outcomes (4)

• Comparison of Surgical Techniques

  One year post-operative, to align with the follow-up period of the primary outcome measure.

• Efficacy of Skin Flap Types

  One year post-operative, to align with the follow-up period of the primary outcome measure.

• Immobilization Method Analysis

  One year post-operative, to align with the follow-up period of the primary outcome measure.

• Preoperative Angle Decision Model

  One year post-operative, to align with the follow-up period of the primary outcome measure.

Study Arms (1)

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

Interventions

Wassel IV Thumb Duplication Surgery PROCEDURE

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.

Wassel IV Thumb Duplication Cases

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Related Publications (4)

• Dautel G, Perrin P. Use of an Axial Flap to Increase the Girth of Wassel IV Thumb Reconstructions. J Hand Surg Am. 2015 Jul;40(7):1327-32. doi: 10.1016/j.jhsa.2015.02.032. Epub 2015 Apr 16.

  PMID: 25892712 RESULT

• Luangjarmekorn P, Virojanawat N, Pongpacharaamphon P, Kitidumrongsook P. Preoperative angulation as a predictor for operations of Wassel type IV polydactyly. J Pediatr Orthop B. 2021 Nov 1;30(6):605-610. doi: 10.1097/BPB.0000000000000806.

  PMID: 32956284 RESULT

• Dijkman R, Selles R, van Rosmalen J, Hulsemann W, Mann M, Habenicht R, Hovius S, van Nieuwenhoven C. A clinically weighted approach to outcome assessment in radial polydactyly. J Hand Surg Eur Vol. 2016 Mar;41(3):265-74. doi: 10.1177/1753193415601336. Epub 2015 Aug 28.

  PMID: 26319288 RESULT

• Kayalar M, Gurbuz Y, Kucuk L, Sugun TS, Ademoglu Y, Ozaksar K. Surgical reconstruction in Wassel type IV thumb duplication. Acta Orthop Traumatol Turc. 2014;48(2):181-6. doi: 10.3944/AOTT.2014.13.0042.

  PMID: 24747627 RESULT

Central Study Contacts

Emeline Bourgeois

CONTACT

0476767575; ebourgeois@chu-grenoble.fr

Aida Mandzo

CONTACT

04 76 76 68 16; amandzo@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: April 22, 2024
• Study Start: April 25, 2024
• Primary Completion: May 6, 2024
• Study Completion: May 15, 2024
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share