Clinical trial NCT06377670: Study of Functional and Aesthetic Outcomes After Wassel IV Thumb Duplication Surgery in Pediatric Population, With a Follow-up of at Least One Year
Official title: 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 type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Wassel IV Thumb Duplication
Keywords: functional outcomes
aesthetic outcomes
pediatric surgery
thumb reconstruction
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional and Aesthetic Outcomes
timeFrame: Up to one year post-surgery for the primary outcome measure time frame
Secondary outcomes:
measure: Comparison of Surgical Techniques
timeFrame: One year post-operative, to align with the follow-up period of the primary outcome measure.
measure: Efficacy of Skin Flap Types
timeFrame: One year post-operative, to align with the follow-up period of the primary outcome measure.
measure: Immobilization Method Analysis
timeFrame: One year post-operative, to align with the follow-up period of the primary outcome measure.
measure: Preoperative Angle Decision Model
timeFrame: One year post-operative, to align with the follow-up period of the primary outcome measure.
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.