- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05742581
Critical Shoulder Angle and Acromial Index on 3D Models
Evaluation of the Relationship Between Critical Shoulder Angle and Acromial Index Measurements With Rotator Cuff Rupture on 3D Models
Objective: The relationship between rotator cuff tears and morphological features of the shoulder joint has not been fully explained. The earlier studies are usually done with two-dimensional radiography images, but joint positions and bone formations could not be fully evaluated in two-dimensional images. This study aims to evaluate the relationship between rotator cuff tears and critical shoulder angle (CSA) and acromial index (AI) values in three dimensions.
Methods: This study examined computerized tomography of 24 rotator cuff tears (rotator cuff tear group) and 20 Bankart lesions, and no rotator cuff tears (control group). CSA and AI were measured on three-dimensional glenohumeral joint models obtained by three-dimensional reconstructions of computed tomography examinations.
The investigators anticipate results of this study will guide clinicians in revealing the etiology of rotator cuff degeneration and determining the surgical method to be used for treatment.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Çankaya
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Ankara, Çankaya, Turkey, 06450
- Yuksek Ihtisas University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- A total of 44 patients, including 24 patients with proven rotator cuff tear by arthroscopic surgery (rotator cuff tear group) and 20 patients with proven Bankart lesion and no rotator cuff tear by arthroscopic surgery (control group), were included in the study.
Exclusion Criteria:
- Those with an inflammatory disease and trauma history were not included in the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Control group
|
In our study, computerized tomography of 24 rotator cuff tears (rotator cuff tear group) and 20 Bankart lesions, and no rotator cuff tears (control group) were examined.
CSA and AI were measured on three-dimensional glenohumeral joint models obtained by three-dimensional reconstructions of computed tomography examinations.
|
|
The rotator cuff tear group
|
In our study, computerized tomography of 24 rotator cuff tears (rotator cuff tear group) and 20 Bankart lesions, and no rotator cuff tears (control group) were examined.
CSA and AI were measured on three-dimensional glenohumeral joint models obtained by three-dimensional reconstructions of computed tomography examinations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Critical Shoulder Angle
Time Frame: 2 hours
|
The critical shoulder angle is defined as the angle formed between the plane of the glenoid and the line connecting the most lateral border of the acromion process, as seen on the true anteroposterior radiograph of the shoulder.
|
2 hours
|
|
Acromial Index
Time Frame: 2 hours
|
The acromial index is the distance between the glenoid plane and the lateral border of the acromion divided by the distance between the glenoid plane and the lateral aspect of the humeral head.
|
2 hours
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12022023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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