Patients That Had Pollicization SurgeryPolliglobalNCT04440384
Long Term Evaluation of Function and Quality of Life After Pollicisation
An observational study of Patients That Had Pollicization Surgery, run by Hospices Civils de Lyon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 7 to 50 years
- Conditions the study is for
- Patients That Had Pollicization Surgery
- What is being tested?
- Functional evaluation
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 2 Sep 2020to 2 Sep 2022
- 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 7 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patient that underwent pollicisation surgery more than 5 years before
Who may be able to join
- 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
Who cannot join
- Patients able to understand the research and to answer to forms
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Patients That Had Pollicization Surgery
- Being tested
- Functional evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, Day 0 (>5 years post-surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start2 Sep 2020
- Primary completion2 Sep 2022
- Study completion2 Sep 2022
Why it stopped: 0 INCLUSION
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients That Had Pollicization SurgeryStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440384
- Sponsor's protocol ID
- 69HCL20_0399
- Acronym
- Polliglobal
- Status last verified
- Nov 2022
- First submitted
- 18 Jun 2020
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Evaluation of Function and Quality of Life After Pollicisation
- ClinicalTrials.gov ID
- NCT04440384
- Acronym / sponsor ID
- Polliglobal / 69HCL20_0399
- Conditions
- Patients That Had Pollicization Surgery
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: 0 INCLUSION
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 2 Sep 2022 (actual)
- Study completion
- 2 Sep 2022 (actual)
- First posted
- 19 Jun 2020 (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 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 7 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patient that underwent pollicisation surgery more than 5 years before
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients able to understand the research and to answer to forms
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 |
|---|---|---|
| Functional evaluationPatients 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 | Other | – |
Primary outcome
T-GAP score
Time frame: At baseline, Day 0 (>5 years post-surgery)
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients That Had Pollicization Surgery, run by Hospices Civils de Lyon at 1 site in France.
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 4 inclusion and 1 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: withdrawn, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T-GAP score (time frame: At baseline, Day 0 (>5 years post-surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Nov 2022.