Joint InstabilityEDLISNCT02401568
Morphologic and Biomechanical Analysis of the Carpal Ligaments
A study testing Dynamic CT and Arthrography in people with Joint Instability and Wrist Injuries, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Joint Instability, Wrist Injuries
- What is being tested?
- Dynamic CT and Arthrography
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to May 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical signs of wrist instability or wrist pain
- Previous medical examination
- Informed consent
- Must have a social security number
Who cannot join
- MR or CT contra-indications
- No prior surgery
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Morphologic and Biomechanical Analysis of the Carpal Ligaments: a Kinematic Study on Dynamic Area Detector CT
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.
Read the 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).
- Conditions
- Joint Instability, Wrist Injuries
- Being tested
- Dynamic CT, Arthrography
- Medical subject headings
- Joint Instability, Wrist Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic CTDevice
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).
ArthrographyProcedure or surgery
percutaneous intra-articular injection of contrast media in the medio-carpal and radio-carpal joints
| Study group | Role | What they receive |
|---|---|---|
| Normal subjects | Other | No morphologic changes in carpal ligaments or clinical signs of wrist instability.
Dynamic CT of the wrist will be performed before and after arthrography. Receives: Device: Dynamic CT; Procedure: Arthrography |
| Wrist instability | Other | Morphologic ligament changes (e.g. partial or complete rupture) Dynamic CT of the wrist will be performed before and after arthrography. Receives: Device: Dynamic CT; Procedure: Arthrography |
What is being measured
The primary outcome is the main question the study is designed to answer.
scapholunate diastasis (mm)
The distance between the scaphoid bone and the lunate bone will be measured during all maneuvers performed
Measured: 1 day
Scapholunate angle
the variation in the scapholunate angle during the maneuvers performed will be assessed
Measured: 1 day
Lunocapitate angle
the variation in the lunocapitate angle during the maneuvers performed will be assessed
Measured: 1 day
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
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2021
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Joint InstabilityStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain Blum, MD, PhD, Study director, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401568
- Sponsor's protocol ID
- 2014-A00845-42
- Acronym
- EDLIS
- Status last verified
- Jul 2020
- First submitted
- 11 Mar 2015
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25656096Garcia-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.
PubMed 23571486Halpenny 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.
PubMed 22137722Troupis 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.
PubMed 23863544Orkut S, Gillet R, Granero J, Hossu G, Douis N, Athlani L, Blum A, Gondim Teixeira PA. Assessment of Scapholunate Instability on 4D CT Scans in Patients with Inconclusive Conventional Images. Radiology. 2023 Sep;308(3):e230193. doi: 10.1148/radiol.230193.
PubMed 37698480
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphologic and Biomechanical Analysis of the Carpal Ligaments: a Kinematic Study on Dynamic Area Detector CT
- ClinicalTrials.gov ID
- NCT02401568
- Acronym / sponsor ID
- EDLIS / 2014-A00845-42
- Conditions
- Joint Instability, Wrist Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Feb 2021 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 30 Mar 2015 (estimated)
- 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.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal subjects | Other | Device: Dynamic CT, Procedure: ArthrographyNo morphologic changes in carpal ligaments or clinical signs of wrist instability. Dynamic CT of the wrist will be performed before and after arthrography. |
| Wrist instability | Other | Device: Dynamic CT, Procedure: ArthrographyMorphologic ligament changes (e.g. partial or complete rupture) Dynamic CT of the wrist will be performed before and after arthrography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical signs of wrist instability or wrist pain
- Previous medical examination
- Informed consent
- Must have a social security number
Key exclusion criteria (3 listed)
- MR or CT contra-indications
- No prior surgery
- Pregnancy
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 |
|---|---|---|
| Dynamic CTVarious 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). | Device | Normal subjects, Wrist instability |
| Arthrographypercutaneous intra-articular injection of contrast media in the medio-carpal and radio-carpal joints | Procedure or surgery | Normal subjects, Wrist instability |
Primary outcome
scapholunate diastasis (mm)
Time frame: 1 day
The distance between the scaphoid bone and the lunate bone will be measured during all maneuvers performed
Scapholunate angle
Time frame: 1 day
the variation in the scapholunate angle during the maneuvers performed will be assessed
Lunocapitate angle
Time frame: 1 day
the variation in the lunocapitate angle during the maneuvers performed will be assessed
Posterior radio scaphoid angle
Time frame: 1 Day
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Results publication: PubMed 25656096Gondim 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 publication: PubMed 23571486Garcia-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 publication: PubMed 22137722Halpenny 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 publication: PubMed 23863544Troupis 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.
- Derived from this study: PubMed 37698480Orkut S, Gillet R, Granero J, Hossu G, Douis N, Athlani L, Blum A, Gondim Teixeira PA. Assessment of Scapholunate Instability on 4D CT Scans in Patients with Inconclusive Conventional Images. Radiology. 2023 Sep;308(3):e230193. doi: 10.1148/radiol.230193.
Related trials for Joint Instability
Active, not recruiting
ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population
Primary Knee Arthroplasty
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Active, not recruitingObservational study
Evaluation of Medium Cross-linked Polyethylene With and Without Vitamin E for Total Knee Arthroplasty
Osteoarthritis, Knee, Arthritis, Rheumatoid
RecruitingObservational study
A Study on Associations Between Multidimensional Human Phenotypic Traits and Human Growth and Development
Musculoskeletal Growth and Development
Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Chronic Ankle Instability, Ankle Sprain
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.
Alain Blum, MD, PhD study director
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic CT and Arthrography in people with Joint Instability and Wrist Injuries, run by Central Hospital, Nancy, France 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 3 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: finished, as of the sponsor's last update on 17 Jun 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
scapholunate diastasis (mm) (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02401568, which also lists 5 linked publications.
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 17 Jun 2025.