NCT04440384

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 2, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2022

Completed
Last Updated

November 30, 2022

Status Verified

November 1, 2022

Enrollment Period

2 years

First QC Date

June 18, 2020

Last Update Submit

November 25, 2022

Conditions

Patients That Had Pollicization Surgery

Outcome Measures

Primary Outcomes (1)

  • 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)

Interventions

Functional evaluationOTHER

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

Eligibility Criteria

Age7 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patient that underwent pollicisation surgery more than 5 years before

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital femme mère enfant

Bron, 69677, France

Location
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2020

First Posted

June 19, 2020

Study Start

September 2, 2020

Primary Completion

September 2, 2022

Study Completion

September 2, 2022

Last Updated

November 30, 2022

Record last verified: 2022-11

Locations

FR(1)