Shoulder Impingement SyndromeACROMIALNCT07889583
Acromial Morphology: Reliability of CT-based Assessment and Relationship With Age in a Series of 420 Patients
An observational study of Shoulder Impingement Syndrome and Acromial Morphology, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
This study evaluates the reliability of CT-based assessment of acromial morphology and its relationship with age, in order to improve understanding of shoulder pathologies such as subacromial impingement and rotator cuff tears. Read more about this study
- Who is it for?
- Ages 20 to 98 years
- Conditions the study is for
- Shoulder Impingement Syndrome, Acromial Morphology
- How many people
- 420 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jan 2026to 22 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 98 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent shoulder CT or arthro-CT at Strasbourg University Hospitals between 2009 and 2023, stratified by age groups, and included for analysis of acromial morphology.
Who may be able to join
- Subjects aged 20 to 89 years
- Shoulder CT or arthro-CT performed at Strasbourg University Hospitals
- Examination performed between 02/01/2009 and 11/12/2023
- Independent indication for imaging
- No documented opposition to reuse of medical data for research
Who cannot join
- Imaging not performed
- Poor image quality
- Inability to perform 3D reconstruction
- Duplicate examination within the same age group
- History of acromial fracture
- Previous surgery interfering with acromial analysis (arthroplasty, acromioplasty, osteosynthesis, arthrodesis)
- Shoulder pathology interfering with acromial analysis (severe acromioclavicular arthropathy, humeral head osteonecrosis, glenohumeral dysplasia)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Chirurgie Orthopédique du Membre Supérieur - CHU de Strasbourg - France
Strasbourg, 67091
Philippe CLAVERT, MD, PhD, 33 3 88 11 67 68, philippe.clavert@chru-strasbourg.fr
Philippe CLAVERT, CLAVERT
About this study
This study evaluates the reliability of CT-based assessment of acromial morphology and its relationship with age, in order to improve understanding of shoulder pathologies such as subacromial impingement and rotator cuff tears.
Read the detailed description
This is a retrospective monocentric observational study conducted at Strasbourg University Hospitals including 420 patients who underwent shoulder CT or arthro-CT between 2009 and 2023. Acromial morphology is assessed using the Bigliani classification on 3D reconstructions. The study evaluates intra- and inter-observer reliability using kappa coefficients and explores the relationship between acromial shape and patient age. Data are collected retrospectively from medical records and imaging software, with repeated assessments performed at 3 and 6 months to evaluate reproducibility.
- Conditions
- Shoulder Impingement Syndrome, Acromial Morphology
- Keywords
- Acromion, Shoulder impingement, Computed tomography
- Medical subject headings
- Shoulder Impingement Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-Rater and Inter-Rater Reliability of the Bigliani Classification of Acromial Morphology
Acromial morphology will be classified as Type I (flat), Type II (curved), or Type III (hooked) according to the Bigliani classification, using 3D-reconstructed shoulder CT scans or CT arthrography images. Intra-rater and inter-rater reliability will be assessed using kappa agreement coefficients (Cohen's kappa and Fleiss' kappa). Five evaluators will assess the images, with repeat evaluations at 3 and 6 months after the initial assessment.
Measured: Initial assessment, with repeat assessments at 3 and 6 months after the initial assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start22 Jan 2026
- Primary completion22 Nov 2026 (estimated)
- Study completion22 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Impingement SyndromeStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889583
- Sponsor's protocol ID
- RC25_0071
- Acronym
- ACROMIAL
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 22 Oct 2026
- 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 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acromial Morphology: Reliability of CT-based Assessment and Relationship With Age in a Series of 420 Patients
- ClinicalTrials.gov ID
- NCT07889583
- Acronym / sponsor ID
- ACROMIAL / RC25_0071
- Conditions
- Shoulder Impingement Syndrome, Acromial Morphology
- Keywords
- Acromion, Shoulder impingement, Computed tomography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- 22 Nov 2026 (estimated)
- Study completion
- 22 Jan 2027 (estimated)
- First posted
- 22 Oct 2026 (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.
This study evaluates the reliability of CT-based assessment of acromial morphology and its relationship with age, in order to improve understanding of shoulder pathologies such as subacromial impingement and rotator cuff tears.
Detailed description
This is a retrospective monocentric observational study conducted at Strasbourg University Hospitals including 420 patients who underwent shoulder CT or arthro-CT between 2009 and 2023. Acromial morphology is assessed using the Bigliani classification on 3D reconstructions. The study evaluates intra- and inter-observer reliability using kappa coefficients and explores the relationship between acromial shape and patient age. Data are collected retrospectively from medical records and imaging software, with repeated assessments performed at 3 and 6 months to evaluate reproducibility.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 98 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent shoulder CT or arthro-CT at Strasbourg University Hospitals between 2009 and 2023, stratified by age groups, and included for analysis of acromial morphology.
Key inclusion criteria (5 listed)
- Subjects aged 20 to 89 years
- Shoulder CT or arthro-CT performed at Strasbourg University Hospitals
- Examination performed between 02/01/2009 and 11/12/2023
- Independent indication for imaging
- No documented opposition to reuse of medical data for research
Key exclusion criteria (7 listed)
- Imaging not performed
- Poor image quality
- Inability to perform 3D reconstruction
- Duplicate examination within the same age group
- History of acromial fracture
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
Intra-Rater and Inter-Rater Reliability of the Bigliani Classification of Acromial Morphology
Time frame: Initial assessment, with repeat assessments at 3 and 6 months after the initial assessment.
Acromial morphology will be classified as Type I (flat), Type II (curved), or Type III (hooked) according to the Bigliani classification, using 3D-reconstructed shoulder CT scans or CT arthrography images. Intra-rater and inter-rater reliability will be assessed using kappa agreement coefficients (Cohen's kappa and Fleiss' kappa). Five evaluators will assess the images, with repeat evaluations at 3 and 6 months after the initial assessment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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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.
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 Shoulder Impingement Syndrome and Acromial Morphology, 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe CLAVERT, MD, PhD (33 3 88 11 67 68, philippe.clavert@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-Rater and Inter-Rater Reliability of the Bigliani Classification of Acromial Morphology (time frame: Initial assessment, with repeat assessments at 3 and 6 months after the initial assessment.). 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 22 Oct 2026.