Morphologic and Biomechanical Analysis of the Carpal Ligaments (EDLIS)
Primary Purpose
Joint Instability, Wrist Injuries
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dynamic CT
Arthrography
Sponsored by
About this trial
This is an interventional diagnostic trial for Joint Instability
Eligibility 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
Sites / Locations
- CentralHNFRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Normal subjects
Wrist instability
Arm Description
No morphologic changes in carpal ligaments or clinical signs of wrist instability. Dynamic CT of the wrist will be performed before and after arthrography.
Morphologic ligament changes (e.g. partial or complete rupture) Dynamic CT of the wrist will be performed before and after arthrography.
Outcomes
Primary Outcome Measures
scapholunate diastasis (mm)
The distance between the scaphoid bone and the lunate bone will be measured during all maneuvers performed
Scapholunate angle
the variation in the scapholunate angle during the maneuvers performed will be assessed
Lunocapitate angle
the variation in the lunocapitate angle during the maneuvers performed will be assessed
Posterior radio scaphoid angle
The angle formed between the posterior most point of the scaphoid in the sagittal plane and the ventral and dorsal rims of the distal radius will be assessed
Secondary Outcome Measures
Full Information
NCT ID
NCT02401568
First Posted
March 11, 2015
Last Updated
March 7, 2016
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT02401568
Brief Title
Morphologic and Biomechanical Analysis of the Carpal Ligaments
Acronym
EDLIS
Official Title
Morphologic and Biomechanical Analysis of the Carpal Ligaments: a Kinematic Study on Dynamic Area Detector CT
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
February 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Compare various dynamic biomechanical markers (distances and angles) in the wrist during dynamic CT studies in three groups of patients: Normal subjects, with scapholunate instability and with other types of wrist instability.
Detailed Description
Patients referred for the evaluation of wrist pain with CT arthrography will be eligible for inclusion. Patients will benefit from dynamic CT acquisitions before and after arthrography with three maneuvers: radio-ulnar deviation, clenching fist and dart throwing motion. Patients will also benefit from a wrist MR study on a 3 tesla scanner.
The morphology of the carpal ligaments will be evaluated on static imaging (MR and CT arthrograph) and on dynamic CT arthrography.
Distance and angular measurements will be obtained from dynamic CT studies using an appropriate post processing tool (4D-Ortho).
Data obtained with dynamic wrist evaluation will be correlated to ligament morphology, classical wrist instability criteria on conventional radiographs and with surgery (if available).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Instability, Wrist Injuries
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Normal subjects
Arm Type
Other
Arm Description
No morphologic changes in carpal ligaments or clinical signs of wrist instability.
Dynamic CT of the wrist will be performed before and after arthrography.
Arm Title
Wrist instability
Arm Type
Other
Arm Description
Morphologic ligament changes (e.g. partial or complete rupture) Dynamic CT of the wrist will be performed before and after arthrography.
Intervention Type
Device
Intervention Name(s)
Dynamic CT
Intervention Description
Various low dose CT acquisitions will be successively performed on the wrist to allow a four dimensional evaluation. The same type of acquisition will be performed during various manoeuvers (radio-ulnar deviation, clenching fist, and dart-throwing motion).
Intervention Type
Procedure
Intervention Name(s)
Arthrography
Intervention Description
percutaneous intra-articular injection of contrast media in the medio-carpal and radio-carpal joints
Primary Outcome Measure Information:
Title
scapholunate diastasis (mm)
Description
The distance between the scaphoid bone and the lunate bone will be measured during all maneuvers performed
Time Frame
1 day
Title
Scapholunate angle
Description
the variation in the scapholunate angle during the maneuvers performed will be assessed
Time Frame
1 day
Title
Lunocapitate angle
Description
the variation in the lunocapitate angle during the maneuvers performed will be assessed
Time Frame
1 day
Title
Posterior radio scaphoid angle
Description
The angle formed between the posterior most point of the scaphoid in the sagittal plane and the ventral and dorsal rims of the distal radius will be assessed
Time Frame
1 Day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pedro Gondim Teixeira, MD, PhD
Phone
0033 3 83 85 21 61
Email
ped_gt@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Chanson, MD
Phone
0033 3 83 85 21 61
Email
an.chanson@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain Blum, MD, PhD
Organizational Affiliation
Central Hospital, Nancy, France
Official's Role
Study Director
Facility Information:
Facility Name
CentralHNF
City
Nancy
State/Province
Lorraine
ZIP/Postal Code
54000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Teixeira, MD, PhD
Phone
0033 3 83 85 21 61
Email
ped_gt@hotmail.com
First Name & Middle Initial & Last Name & Degree
Anne Chanson, MD
Phone
0033 3 83 85 21 61
Email
an.chanson@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
25656096
Citation
Gondim Teixeira PA, Gervaise A, Louis M, Lecocq S, Raymond A, Aptel S, Blum A. Musculoskeletal wide detector CT: principles, techniques and applications in clinical practice and research. Eur J Radiol. 2015 May;84(5):892-900. doi: 10.1016/j.ejrad.2014.12.033. Epub 2015 Jan 17.
Results Reference
result
PubMed Identifier
23571486
Citation
Garcia-Elias M, Alomar Serrallach X, Monill Serra J. Dart-throwing motion in patients with scapholunate instability: a dynamic four-dimensional computed tomography study. J Hand Surg Eur Vol. 2014 May;39(4):346-52. doi: 10.1177/1753193413484630. Epub 2013 Apr 8.
Results Reference
result
PubMed Identifier
22137722
Citation
Halpenny D, Courtney K, Torreggiani WC. Dynamic four-dimensional 320 section CT and carpal bone injury - a description of a novel technique to diagnose scapholunate instability. Clin Radiol. 2012 Feb;67(2):185-7. doi: 10.1016/j.crad.2011.10.002. Epub 2011 Dec 3. No abstract available.
Results Reference
result
PubMed Identifier
23863544
Citation
Troupis JM, Amis B. Four-dimensional computed tomography and trigger lunate syndrome. J Comput Assist Tomogr. 2013 Jul-Aug;37(4):639-43. doi: 10.1097/RCT.0b013e31828b68ec.
Results Reference
result
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Morphologic and Biomechanical Analysis of the Carpal Ligaments
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