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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: Procedure: Arthroscopic rotator cuff repair

• Study Type: Interventional
• Enrollment (Anticipated): 38
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 anterior part were categorized in the anterior tear group.	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.
Experimental: 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 middle part were categorized in the middle tear group.	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.
Experimental: Posterior 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 29, 2022
• Primary Completion (Anticipated): August 15, 2022
• Study Completion (Anticipated): August 22, 2022

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: July 27, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: rotator cuff tear; long head of the bicep tendon; cross-sectional area
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: IIT-2022-0028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

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