Rotator Cuff TearsNCT05484271
Relationship Between the Arthroscopic Anatomy of the Middle Glenohumeral Ligament and the Rotator Cuff Tear Position
An observational study of Rotator Cuff Tears, run by RenJi Hospital.
Trial summary
The main aim and scope of this study is making observation and comparing the difference in the tear position in the patients suffered form rotator cuff tear with different arthroscopic anatomy of the middle glenohumeral ligament. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Rotator cuff repair
- Type of treatment
- Surgery or procedure
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- 5 Aug 2022to 28 Aug 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with rotator cuff tears received the arthroscopic rotator cuff repair.
Who may be able to join
- partial or full-thickness but reparable rotator cuff tear;
- small- to large-sized rotator cuff tears being defined by DeOrio and Cofied4;
- no improvements after at least 1 month of conservative treatment such as NSAIDs or corticosteroid injection.
Who cannot join
- massive rotator cuff tears being defined by DeOrio and Cofied;
- patients with osteoarthritis of the glenohumeral joint;
- trauma or a history of surgery at the shoulder.
About this study
The main aim and scope of this study is making observation and comparing the difference in the tear position in the patients suffered form rotator cuff tear with different arthroscopic anatomy of the middle glenohumeral ligament. The results may identify the influence of the middle glenohumeral ligament anatomy type on the rotator cuff tear.
- Conditions
- Rotator Cuff Tears
- Being tested
- Rotator cuff repair
- Keywords
- Rotator Cuff Tears, Middle Glenohumeral Ligament, Arthroscopic Anatomy
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotator cuff repairProcedure or surgery
The patients received the arthroscopic rotator cuff repair.
| Study group | Role | What they receive |
|---|---|---|
| Leaf-like and Cord-like type | Under arthroscopy, the anatomy of middle glenohumeral ligament was leaf-like or cord-like. Receives: Procedure: Rotator cuff repair | |
| Absent type | Under arthroscopy, the anatomy of middle glenohumeral ligament was absent. Receives: Procedure: Rotator cuff repair | |
| Burford complex type | Under arthroscopy, the anatomy of middle glenohumeral ligament manifested the burford complex. Receives: Procedure: Rotator cuff repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
The arthroscopic tear position (Anetrior/Middle/Posterior)
The rotator cuff was divided into three parts according to the arthroscopic discovery: (1) the anterior part which contained the subsacpularis and one third of the suprascapularis forward; (2) the middle part which contained the two thirds of the suprascapularis backward and one third of the subscapularis forward; (3) the posterior part which contained two thirds of subscapularis backward and teres minor.
Measured: During the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start5 Aug 2022 (estimated)
- Primary completion20 Aug 2022 (estimated)
- Study completion28 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484271
- Sponsor's protocol ID
- IIT-2022-0074
- Status last verified
- Jul 2022
- First submitted
- 1 Aug 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between the Arthroscopic Anatomy of the Middle Glenohumeral Ligament and the Rotator Cuff Tear Position
- ClinicalTrials.gov ID
- NCT05484271
- Acronym / sponsor ID
- IIT-2022-0074
- Conditions
- Rotator Cuff Tears
- Keywords
- Rotator Cuff Tears, Middle Glenohumeral Ligament, Arthroscopic Anatomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 5 Aug 2022 (estimated)
- Primary completion
- 20 Aug 2022 (estimated)
- Study completion
- 28 Aug 2022 (estimated)
- First posted
- 2 Aug 2022 (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.
The main aim and scope of this study is making observation and comparing the difference in the tear position in the patients suffered form rotator cuff tear with different arthroscopic anatomy of the middle glenohumeral ligament. The results may identify the influence of the middle glenohumeral ligament anatomy type on the rotator cuff tear.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Leaf-like and Cord-like type | – | Procedure: Rotator cuff repairUnder arthroscopy, the anatomy of middle glenohumeral ligament was leaf-like or cord-like. |
| Absent type | – | Procedure: Rotator cuff repairUnder arthroscopy, the anatomy of middle glenohumeral ligament was absent. |
| Burford complex type | – | Procedure: Rotator cuff repairUnder arthroscopy, the anatomy of middle glenohumeral ligament manifested the burford complex. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with rotator cuff tears received the arthroscopic rotator cuff repair.
Key inclusion criteria (3 listed)
- partial or full-thickness but reparable rotator cuff tear;
- small- to large-sized rotator cuff tears being defined by DeOrio and Cofied4;
- no improvements after at least 1 month of conservative treatment such as NSAIDs or corticosteroid injection.
Key exclusion criteria (3 listed)
- massive rotator cuff tears being defined by DeOrio and Cofied;
- patients with osteoarthritis of the glenohumeral joint;
- trauma or a history of surgery at the shoulder.
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 |
|---|---|---|
| Rotator cuff repairThe patients received the arthroscopic rotator cuff repair. | Procedure or surgery | Absent type, Burford complex type, Leaf-like and Cord-like type |
Primary outcome
The arthroscopic tear position (Anetrior/Middle/Posterior)
Time frame: During the surgery
The rotator cuff was divided into three parts according to the arthroscopic discovery: (1) the anterior part which contained the subsacpularis and one third of the suprascapularis forward; (2) the middle part which contained the two thirds of the suprascapularis backward and one third of the subscapularis forward; (3) the posterior part which contained two thirds of subscapularis backward and teres minor.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tears, run by RenJi Hospital.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
The arthroscopic tear position (Anetrior/Middle/Posterior) (time frame: During the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2022.