Perilunate DislocationCARPUSNCT05458921
Development of Automated Real-time Algorithms for Detection of Dislocation of the Carpus
An observational study of Perilunate Dislocation, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Perilunate dislocation of the carpus is a serious lesion of the wrist which is defined by a total loss of contact of the articular surfaces capito-lunar, scapholunate and lunate-triquetral. Rare by its frequency, it represents 5 to 10% of traumatic injuries of the wrist. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perilunate Dislocation
- How many people
- 10,100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2022to 31 Dec 2023
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Major subjects (≥18 years old) treated at the University Hospitals of Strasbourg for a carpal dislocation between 01/01/2012 and 31/12/2022.
Who may be able to join
- Major subjects (≥18 years old)
- Treated at the University Hospitals of Strasbourg for a carpal dislocation
- Presence of carpal radiographs that may indicate the presence of a lesion
- Subjects who have not expressed their opposition, after information, to the re-use of their data for the purposes of this research
Who cannot join
- Subject having expressed his opposition to participate in the study
- Subject under legal protection, guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
Saïd CHAYER, PhD, HDR contact
France1 site, 1 recruiting
- Recruiting
Service de Chirurgie de la main - CHU de Strasbourg - France
Strasbourg, 67091
Philippe LIVERNEAUX, MD, PhD, 33 3 68 76 52 48, philippe.liverneaux@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, said.chayer@chru-strasbourg.fr
About this study
Official title: Study CARPUS : " Development of Automated Real-time Algorithms for Detection of Dislocation of the Carpus "
Perilunate dislocation of the carpus is a serious lesion of the wrist which is defined by a total loss of contact of the articular surfaces capito-lunar, scapholunate and lunate-triquetral. Rare by its frequency, it represents 5 to 10% of traumatic injuries of the wrist.
Perilunate wrist dislocation is a rare injury that goes unnoticed in 25% of cases. Even with surgical treatment, 50-100% of patients will develop radiocarpal and/or midcarpal osteoarthritis.
- Conditions
- Perilunate Dislocation
- Keywords
- Perilunate dislocation, Carpus dislocation, Radiocarpal osteoarthritis, mid-carpal osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective analysis of carpal X-rays for the development of an algorithm to automatically identify the presence of pathology in the carpal anatomical area
Measured: Files analysed retrospectively from January 01, 2012 to December 31, 2022 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start1 Jun 2022
- Primary completionDec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perilunate DislocationStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe LIVERNEAUX, MD, PhD, Principal investigator, Service de Chirurgie de la main - CHU de Strasbourg - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458921
- Sponsor's protocol ID
- 8559
- Acronym
- CARPUS
- Status last verified
- Nov 2023
- First submitted
- 8 Jul 2022
- Last updated
- 8 Nov 2023
- 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 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study CARPUS : " Development of Automated Real-time Algorithms for Detection of Dislocation of the Carpus "
- ClinicalTrials.gov ID
- NCT05458921
- Acronym / sponsor ID
- CARPUS / 8559
- Conditions
- Perilunate Dislocation
- Keywords
- Perilunate dislocation, Carpus dislocation, Radiocarpal osteoarthritis, mid-carpal osteoarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Jul 2022 (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.
Perilunate dislocation of the carpus is a serious lesion of the wrist which is defined by a total loss of contact of the articular surfaces capito-lunar, scapholunate and lunate-triquetral. Rare by its frequency, it represents 5 to 10% of traumatic injuries of the wrist.
Perilunate wrist dislocation is a rare injury that goes unnoticed in 25% of cases. Even with surgical treatment, 50-100% of patients will develop radiocarpal and/or midcarpal osteoarthritis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Major subjects (≥18 years old) treated at the University Hospitals of Strasbourg for a carpal dislocation between 01/01/2012 and 31/12/2022.
Key inclusion criteria (4 listed)
- Major subjects (≥18 years old)
- Treated at the University Hospitals of Strasbourg for a carpal dislocation
- Presence of carpal radiographs that may indicate the presence of a lesion
- Subjects who have not expressed their opposition, after information, to the re-use of their data for the purposes of this research
Key exclusion criteria (2 listed)
- Subject having expressed his opposition to participate in the study
- Subject under legal protection, guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retrospective analysis of carpal X-rays for the development of an algorithm to automatically identify the presence of pathology in the carpal anatomical area
Time frame: Files analysed retrospectively from January 01, 2012 to December 31, 2022 will be examined]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
Related trials for Perilunate Dislocation
RecruitingObservational study
A 4-Anchor Construct With Internal Bracing Technique for Surgical Treatment of Perilunate Dislocations
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The Canadian Prospective Pragmatic Perilunate Outcomes Trial
Wrist Injuries, Carpal Bone Fracture
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.
Saïd CHAYER, PhD, HDR contact
Philippe LIVERNEAUX, MD, PhD principal investigator
Service de Chirurgie de la main - CHU de Strasbourg - France
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 Perilunate Dislocation, run by University Hospital, Strasbourg, 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 2 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: status not confirmed, as of the sponsor's last update on 8 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe LIVERNEAUX, MD, PhD (33 3 68 76 52 48, philippe.liverneaux@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective analysis of carpal X-rays for the development of an algorithm to automatically identify the presence of pathology in the carpal anatomical area (time frame: Files analysed retrospectively from January 01, 2012 to December 31, 2022 will be examined]). 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 8 Nov 2023.