NCT05742581

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
Last Updated

February 24, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

February 11, 2023

Last Update Submit

February 22, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

The rotator cuff tear group

Other: Computed Tomography

Control group

Other: Computed Tomography

Interventions

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.

Control groupThe rotator cuff tear group

Eligibility Criteria

Age17 Years - 80 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In this study, computed tomography examinations of patients who applied to Gazi University Faculty of Medicine Department of Orthopedics and Traumatology between 2016-2019 were examined retrospectively.

You may qualify if:

  • 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.

You may not qualify if:

  • Those with an inflammatory disease and trauma history were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuksek Ihtisas University

Ankara, Çankaya, 06450, Turkey (Türkiye)

Location

Related 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.

    PMID: 30573908BACKGROUND

MeSH Terms

Conditions

Shoulder InjuriesRotator Cuff Injuries

Condition Hierarchy (Ancestors)

Wounds and InjuriesRuptureTendon Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Teaching Assistant, Lecturer

Study Record Dates

First Submitted

February 11, 2023

First Posted

February 24, 2023

Study Start

June 1, 2019

Primary Completion

August 30, 2019

Study Completion

September 30, 2019

Last Updated

February 24, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations