- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05484271
Relationship Between the Arthroscopic Anatomy of the Middle Glenohumeral Ligament and the Rotator Cuff Tear Position
August 1, 2022 updated by: RenJi Hospital
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 Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
125
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with rotator cuff tears received the arthroscopic rotator cuff repair.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Leaf-like and Cord-like type
Under arthroscopy, the anatomy of middle glenohumeral ligament was leaf-like or cord-like.
|
The patients received the arthroscopic rotator cuff repair.
|
|
Absent type
Under arthroscopy, the anatomy of middle glenohumeral ligament was absent.
|
The patients received the arthroscopic rotator cuff repair.
|
|
Burford complex type
Under arthroscopy, the anatomy of middle glenohumeral ligament manifested the burford complex.
|
The patients received the arthroscopic rotator cuff repair.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
During the surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 5, 2022
Primary Completion (Anticipated)
August 20, 2022
Study Completion (Anticipated)
August 28, 2022
Study Registration Dates
First Submitted
August 1, 2022
First Submitted That Met QC Criteria
August 1, 2022
First Posted (Actual)
August 2, 2022
Study Record Updates
Last Update Posted (Actual)
August 2, 2022
Last Update Submitted That Met QC Criteria
August 1, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIT-2022-0074
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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