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
• Status: Completed
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears
• Shoulder Injuries
• Wounds and Injuries

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