The Cross-sectional Area of the Long Head of the Biceps Tendon and the Rotator Cuff Tear Position

Rotator Cuff Tears Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05477771
• Other study ID #: IIT-2022-0028
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 29, 2022
• Est. completion date: August 22, 2022

Study information

• Verified date: July 2022
• Source: RenJi Hospital
• Contact: Lin Du
• Phone: 86-13817371926
• Email: sato316[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 38
• Est. completion date: August 22, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

Procedure:
• Arthroscopic rotator cuff repair
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	2 months after the surgery