Wassel IV Thumb DuplicationNCT06377670
Study of Functional and Aesthetic Outcomes After Wassel IV Thumb Duplication Surgery in Pediatric Population, With a Follow-up of at Least One Year
An observational study of Wassel IV Thumb Duplication, run by University Hospital, Grenoble.
Trial summary
The purpose of this study is to evaluate the functional and aesthetic outcomes in children with Wassel IV thumb duplication Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Wassel IV Thumb Duplication
- What is being tested?
- Wassel IV Thumb Duplication Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 25 Apr 2024to 15 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- Subjects under guardianship or deprived of liberty
- Opposition from legal guardians or from the patient to participate in the study
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study is to evaluate the functional and aesthetic outcomes in children with Wassel IV thumb duplication
Read the 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.
- Conditions
- Wassel IV Thumb Duplication
- Being tested
- Wassel IV Thumb Duplication Surgery
- Keywords
- functional outcomes, aesthetic outcomes, pediatric surgery, thumb reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wassel IV Thumb Duplication SurgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Wassel IV Thumb Duplication Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to one year post-surgery for the primary outcome measure time frame
Secondary outcomes (4)
Comparison of Surgical Techniques
Evaluate which surgical reconstruction techniques yield better functional and aesthetic outcomes.
Soft tissue reconstruction only or need for osteotomy.
Measured: One year post-operative, to align with the follow-up period of the primary outcome measure.
Efficacy of Skin Flap Types
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.
Measured: One year post-operative, to align with the follow-up period of the primary outcome measure.
Immobilization Method Analysis
Determine the effectiveness of various immobilization methods post-surgery. Plaster immobilization or splint, with or without wire.
Measured: One year post-operative, to align with the follow-up period of the primary outcome measure.
Preoperative Angle Decision Model
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.
Measured: One year post-operative, to align with the follow-up period of the primary outcome measure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start25 Apr 2024 (estimated)
- Primary completion6 May 2024 (estimated)
- Study completion15 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Wassel IV Thumb DuplicationStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377670
- Sponsor's protocol ID
- 38RC24.0012
- Status last verified
- Apr 2024
- First submitted
- 5 Mar 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25892712Luangjarmekorn 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.
PubMed 32956284Dijkman 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.
PubMed 26319288Kayalar 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.
PubMed 24747627
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06377670
- Acronym / sponsor ID
- 38RC24.0012
- Conditions
- Wassel IV Thumb Duplication
- Keywords
- functional outcomes, aesthetic outcomes, pediatric surgery, thumb reconstruction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 25 Apr 2024 (estimated)
- Primary completion
- 6 May 2024 (estimated)
- Study completion
- 15 May 2024 (estimated)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wassel IV Thumb Duplication Cases | – | Procedure: Wassel IV Thumb Duplication SurgeryThis 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. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Subjects under guardianship or deprived of liberty
- Opposition from legal guardians or from the patient to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wassel IV Thumb Duplication SurgeryThis 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. | Procedure or surgery | Wassel IV Thumb Duplication Cases |
Primary outcome
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.
4 secondary outcomes
Comparison of Surgical Techniques
Time frame: 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.
Immobilization Method Analysis
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Results publication: PubMed 25892712Dautel 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.
- Results publication: PubMed 32956284Luangjarmekorn 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.
- Results publication: PubMed 26319288Dijkman 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.
- Results publication: PubMed 24747627Kayalar 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Wassel IV Thumb Duplication, run by University Hospital, Grenoble.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emeline Bourgeois (0476767575, ebourgeois@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional and Aesthetic Outcomes (time frame: Up to one year post-surgery for the primary outcome measure time frame). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06377670, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.