Long Term Evaluation of Function and Quality of Life After Pollicisation (Polliglobal)

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.

Study Overview

• Status: Withdrawn
• Conditions: Patients That Had Pollicization Surgery
• Intervention / Treatment: Other: Functional evaluation

• Study Type: Observational

Contacts and Locations

Study Locations

• France
  • Bron, France, 69677
    • Hopital Femme Mere Enfant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 50 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient that underwent pollicisation surgery more than 5 years before

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 2, 2020
• Primary Completion (ACTUAL): September 2, 2022
• Study Completion (ACTUAL): September 2, 2022

Study Registration Dates

• First Submitted: June 18, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (ACTUAL): June 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 25, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 69HCL20_0399

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No