Long Term Evaluation of Function and Quality of Life After Pollicisation

Patients That Had Pollicization Surgery Clinical Trial

— Polliglobal  

Official title:

Long Term Evaluation of Function and Quality of Life After Pollicisation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04440384
• Other study ID #: 69HCL20_0399
• Status: Withdrawn
• Start date: September 2, 2020
• Est. completion date: September 2, 2022

Study information

• Verified date: November 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study aims at describing long term functional outcome of patients that underwent pollicisation surgery.

The hypothesis of the study is that there are prognostic factors of good function results of pollicisation (based on T-GAP classification for function) that will be searched on univariate and multivariate analysis.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2, 2022
• Est. primary completion date: September 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 50 Years

Eligibility

Inclusion Criteria:

• More than 7 years and less than 50 years

• Underwent unilateral or bilateral pollicisation surgery

• For children : non opposition of the parents

• For adults : non opposition

Exclusion Criteria:

• Patients able to understand the research and to answer to forms

Related Conditions & MeSH terms

• Patients That Had Pollicization Surgery

Intervention

Other:
• Functional evaluation
Patients will complete these forms and tests : Box and block test, Purdue peg board, Percival, Nine hole peg, T-GAP, EGF, MAHVIE, DASH, RAND36, CHQ-PF28, CHQ-CF45, CGI-S

Locations

Country	Name	City	State
France	Hôpital femme mère enfant	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T-GAP score	The Thumb Grasp and Pinch assessment (T-GAP) is a new outcome measure that classifies grasp and pinch styles to quantify use of the new thumb.; Scoring is based on principles of hand development and skill using a 7-point hierarchical scale including abnormal (scores of 1e3) and normal (scores of 4e7) grasp patterns, with more mature patterns receiving higher points.	At baseline, Day 0 (>5 years post-surgery)