Back to resultsThe Cross-sectional Area of the Long Head of the Biceps Tendon and the Rotator Cuff Tear Position
Primary Purpose
Rotator Cuff Tears
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Arthroscopic rotator cuff repair
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tears focused on measuring long head of the bicep tendon, rotator cuff tear, cross-sectional area
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Anterior tear group
Middle tear group
Posterior tear group
Arm Description
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. The patients with rotator cuff tear at the anterior part were categorized in the anterior tear group.
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. The patients with rotator cuff tear at the middle part were categorized in the middle tear group.
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. The patients with rotator cuff tear at the posterior part were categorized in the posterior tear group.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Post-operative measurement of the cross-sectional area of the long head of bicep
According to the MRI scan 2 months after the surgery, 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05477771
Brief Title
The Cross-sectional Area of the Long Head of the Biceps Tendon and the Rotator Cuff Tear Position
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 29, 2022 (Anticipated)
Primary Completion Date
August 15, 2022 (Anticipated)
Study Completion Date
August 22, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears
Keywords
long head of the bicep tendon, rotator cuff tear, cross-sectional area
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anterior tear group
Arm Type
Experimental
Arm Description
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. The patients with rotator cuff tear at the anterior part were categorized in the anterior tear group.
Arm Title
Middle tear group
Arm Type
Experimental
Arm Description
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. The patients with rotator cuff tear at the middle part were categorized in the middle tear group.
Arm Title
Posterior tear group
Arm Type
Experimental
Arm Description
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. The patients with rotator cuff tear at the posterior part were categorized in the posterior tear group.
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic rotator cuff repair
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pre-operative measurement of the cross-sectional area of the long head of bicep tendon
Description
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.
Time Frame
Pre-operative
Secondary Outcome Measure Information:
Title
Post-operative measurement of the cross-sectional area of the long head of bicep
Description
According to the MRI scan 2 months after the surgery, 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.
Time Frame
2 months after the surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Du
Phone
86-13817371926
Email
sato316@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Du
Organizational Affiliation
RenJi Hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Cross-sectional Area of the Long Head of the Biceps Tendon and the Rotator Cuff Tear Position
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