The Cross-sectional Area of the Long Head of the Biceps Tendon and the Rotator Cuff Tear Position
The Correlation Between the Cross-sectional Area of the Long Head of the Biceps Tendon and the Tear Position in Patients With Rotator Cuff Tears
1 other identifier
interventional
38
0 countries
N/A
Brief Summary
The main aim and scope of this study is making measurement and comparison of the cross-sectional area of the long head of the biceps tendon(LHBT) in the patients suffered form rotator cuff tear with different tear positions, and making observation and comparison of the impairment type of the LHBT in the patients suffered from rotator cuff tear with different tear positions. The results may identify the influence of the tear position on the LHBT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2022
Shorter than P25 for not_applicable
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
First Submitted
Initial submission to the registry
July 25, 2022
CompletedFirst Posted
Study publicly available on registry
July 28, 2022
CompletedStudy Start
First participant enrolled
July 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2022
CompletedJuly 28, 2022
July 1, 2022
17 days
July 25, 2022
July 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pre-operative measurement of the cross-sectional area of the long head of bicep tendon
According to the pre-operative MRI scan, two sites of the long head of biceps tendon were measured by the Image-Pro Plus 6.0 software. One was the plane that passed the center of the glenoid cavity, the other one was the plane that passed the distal border of the glenoid cavity. The contour of the long head of biceps tendon was traced and the area was calculated by the software according to the MRI's scale.
Pre-operative
Secondary Outcomes (1)
Post-operative measurement of the cross-sectional area of the long head of bicep
2 months after the surgery
Study Arms (3)
Anterior tear group
EXPERIMENTALThe 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. The patients with rotator cuff tear at the anterior part were categorized in the anterior tear group.
Middle tear group
EXPERIMENTALThe 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. The patients with rotator cuff tear at the middle part were categorized in the middle tear group.
Posterior tear group
EXPERIMENTALThe 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. The patients with rotator cuff tear at the posterior part were categorized in the posterior tear group.
Interventions
The rotator cuff tears were repaired under arthroscopy. A subacromial decompression was performed in all patients. Then the long head of the biceps with severe lesions were treated by tenotomy while the others were reserved according to the surgeon's judgment during the surgery.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RenJi Hospitallead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lin Du
RenJi Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2022
First Posted
July 28, 2022
Study Start
July 29, 2022
Primary Completion
August 15, 2022
Study Completion
August 22, 2022
Last Updated
July 28, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share