|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
11 April 2016 |
|
Main ID: |
NCT02401568 |
|
Date of registration:
|
11/03/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Morphologic and Biomechanical Analysis of the Carpal Ligaments
EDLIS |
|
Scientific title:
|
Morphologic and Biomechanical Analysis of the Carpal Ligaments: a Kinematic Study on Dynamic Area Detector CT |
|
Date of first enrolment:
|
February 2015 |
|
Target sample size:
|
300 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT02401568 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Pedro Teixeira, MD, PhD |
|
Address:
|
|
|
Telephone:
|
0033 3 83 85 21 61 |
|
Email:
|
ped_gt@hotmail.com |
|
Affiliation:
|
|
|
|
Name:
|
Alain Blum, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Central Hospital, Nancy, France |
|
|
Name:
|
Pedro Gondim Teixeira, MD, PhD |
|
Address:
|
|
|
Telephone:
|
0033 3 83 85 21 61 |
|
Email:
|
ped_gt@hotmail.com |
|
Affiliation:
|
|
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Clinical signs of wrist instability or wrist pain
- Previous medical examination
- Informed consent
- Must have a social security number
Exclusion Criteria:
- MR or CT contra-indications
- No prior surgery
- Pregnancy
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Joint Instability
|
|
Wrist Injuries
|
|
Intervention(s)
|
|
Procedure: Arthrography
|
|
Device: Dynamic CT
|
|
Primary Outcome(s)
|
|
scapholunate diastasis (mm)
[Time Frame: 1 day]
|
|
Lunocapitate angle
[Time Frame: 1 day]
|
|
Posterior radio scaphoid angle
[Time Frame: 1 Day]
|
|
Scapholunate angle
[Time Frame: 1 day]
|
|
Secondary ID(s)
|
|
2014-A00845-42
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|