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NCT05742581 Clinical Trial

Critical Shoulder Angle and Acromial Index on 3D Models

Rotator Cuff Tears Clinical Trial

Official title:
Evaluation of the Relationship Between Critical Shoulder Angle and Acromial Index Measurements With Rotator Cuff Rupture on 3D Models

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05742581
Other study ID # 12022023
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2019
Est. completion date September 30, 2019

Study information
Verified date February 2023
Source Yuksek Ihtisas University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date September 30, 2019
Est. primary completion date August 30, 2019
Accepts healthy volunteers
Gender All
Age group 17 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Computed Tomography
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.

Locations
Country Name City State
Turkey Yuksek Ihtisas University Ankara Çankaya

Sponsors (1)
Lead Sponsor Collaborator
Merve Sevgi INCE

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Watanabe A, Ono Q, Nishigami T, Hirooka T, Machida H. Association between the Critical Shoulder Angle and Rotator Cuff Tears in Japan. Acta Med Okayama. 2018 Dec;72(6):547-551. doi: 10.18926/AMO/56371. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Critical Shoulder Angle 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
Primary Acromial Index 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
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