Shoulder InjuriesNCT05742581
Critical Shoulder Angle and Acromial Index on 3D Models
An observational study of Shoulder Injuries and Rotator Cuff Tears, run by Merve Sevgi INCE at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 17 to 80 years
- Conditions the study is for
- Shoulder Injuries, Rotator Cuff Tears, Rotator Cuff Injuries
- What is being tested?
- Computed Tomography
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2019to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 17 to 80 years
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Those with an inflammatory disease and trauma history were not included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yuksek Ihtisas University
Ankara, Çankaya, 06450
About this study
Official title: 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.
- Conditions
- Shoulder Injuries, Rotator Cuff Tears, Rotator Cuff Injuries
- Being tested
- Computed Tomography
- Medical subject headings
- Shoulder Injuries, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| The rotator cuff tear group | Not described Receives: Other: Computed Tomography | |
| Control group | Not described Receives: Other: Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start1 Jun 2019
- Primary completion30 Aug 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder InjuriesStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merve Sevgi INCE
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Merve Sevgi INCE, Yuksek Ihtisas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742581
- Sponsor's protocol ID
- 12022023
- Status last verified
- Feb 2023
- First submitted
- 11 Feb 2023
- Last updated
- 24 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30573908
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Critical Shoulder Angle and Acromial Index Measurements With Rotator Cuff Rupture on 3D Models
- ClinicalTrials.gov ID
- NCT05742581
- Acronym / sponsor ID
- 12022023
- Conditions
- Shoulder Injuries, Rotator Cuff Tears, Rotator Cuff Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Merve Sevgi INCEUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 24 Feb 2023 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The rotator cuff tear group | – | Other: Computed Tomography |
| Control group | – | Other: Computed Tomography |
Who may qualify
- Ages
- 17 to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Those with an inflammatory disease and trauma history were not included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed TomographyIn 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. | Other | Control group, The rotator cuff tear group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Background: PubMed 30573908Watanabe 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Injuries and Rotator Cuff Tears, run by Merve Sevgi INCE at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Feb 2023. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Critical Shoulder Angle (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05742581, which also lists 1 linked publication.
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 24 Feb 2023.