Rotator Cuff Tears Treated With Long Head of the Biceps Reinforcement

Evaluation of Rotator Cuff Repair With Long Head of the Biceps Reinforcement: a Prospective Randomized Study

The increase of the population life expectancy and the active lifestyle adopted in recent years have contributed to the higher incidence of rotator cuff injuries. For large (>3 cm) and extensive (>5 cm) injuries of the rotator cuff, even after complete or partial repair, the chances of failure reach 94%.

An alternative in rotator cuff injuries is the use of the long head of the biceps (LHB) as an autologous graft to increase the healing rate and the final outcomes.

The primary objective is to compare the functional results, according to the ASES score, between patients who use or not the long head biceps brace for complete repairs of large and extensive rotator cuff tears.

The secondary objectives are to compare the groups according to structural results by MRI and functional results by the UCLA score.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Injuries; Biceps Tendon Reattachment
• Intervention / Treatment: Procedure: LHB tendon reinforcement; Procedure: complete repair without reinforcement

Detailed Description

A prospective randomized study will be carried out in a 1:1 ratio between groups. Patients with large and extensive rotator cuff injuries will be selected at the Shoulder and Elbow clinic of Pedro Ernesto University Hospital (HUPE-UERJ), during outpatient care.

Patients with an intact long head of the biceps will be randomized into two groups, according to the use or not of the tendon: complete repair with LHB tendon reinforcement and complete repair without reinforcement. All patients will be operated by the same surgeon.

All selected patients will be explained what the research is about by a research assistant not involved in the treatment and will be offered the option to participate or not.

The "American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form" (ASES) scale will be adopted as the primary outcome. The "Modified University of California at Los Angeles Shoulder Rating Scale" (UCLA) and the assessment of tendon healing with magnetic resonance imaging at 6 months after surgery, using the classification of Sugaya et al. will be secondary outcomes.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 20551-030
    • Hospital Universitário Pedro Ernesto

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Long head tendon of biceps intact;
• Large or extensive posterosuperior rotator cuff injuries according to the classification of DeOrio and Cofield;20
• Fatty degeneration of the ≦2 supraspinatus muscle according to the classification of Goutallier.21

Exclusion Criteria:

• Active or previous infection in the affected shoulder;
• Patients unable to understand preoperative questionnaires;
• Patient who does not undergo at least 1 postoperative evaluation.
• Injury where complete repair of the rotator cuff is not possible;
• Rupture of the LHB tendon diagnosed intraoperatively.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: complete repair with LHB tendon reinforcement	Procedure: LHB tendon reinforcement; complete repair with LHB tendon reinforcement
Active Comparator: complete repair without reinforcement; complete repair without reinforcement.	Procedure: complete repair without reinforcement; conventional rotator cuff complete repair without reinforcement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue score (VAS)	Visual analogue score: it is a 10 cm line with two end points, one representing "no pain" and the other representing "worst pain". The patient marks the line to indicate their current pain level, and the distance from the "no pain" marker to the mark is measured in centimeters to provide a score. A higher score indicates greater pain intensity.	24 months
Structural outcomes	Patients will undergo preoperative MRI and from 6 months after the procedure. All images will be evaluated by at least two authors of the work, who will not know which group the patients belong to. The classification by Sugaya et al. stratifies the appearance of the tendon after repair into 5 types: type I (sufficient thickness with low signal in all images); type II (sufficiently thick with high focal signal); type III (insufficient thickness without discontinuity); type IV (small size tear) and type V (medium or large size tear). The healing of the long head biceps reinforcement will also be evaluated by MRI and classified as unhealed and healed.	24 months
American Shoulder and Elbow Score (ASES)	American Shoulder and Elbow Score score ranges from 0 to 100, with 0 the lowest level of function and 100 the highest level of function.	24
The University of California-Los Angeles (UCLA)	Scores ranged from 0 to 35 with a score of 0 indicating worst shoulder function and 35 indicating best shoulder function.	24 months
The 12 item Short Form Survey (SF-12)	This is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. Utilize the norm-based scoring system to interpret Physical component and Mental component scores, with a mean of 50 and a standard deviation of 10 in the general population. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.	24 months

Collaborators and Investigators

• Sponsor: Hospital Universitario Pedro Ernesto

Publications and helpful links

General Publications

• Barth J, Olmos MI, Swan J, Barthelemy R, Delsol P, Boutsiadis A. Superior Capsular Reconstruction With the Long Head of the Biceps Autograft Prevents Infraspinatus Retear in Massive Posterosuperior Retracted Rotator Cuff Tears. Am J Sports Med. 2020 May;48(6):1430-1438. doi: 10.1177/0363546520912220. Epub 2020 Apr 8.
• Rhee SM, Youn SM, Park JH, Rhee YG. Biceps Rerouting for Semirigid Large-to-Massive Rotator Cuff Tears. Arthroscopy. 2021 Sep;37(9):2769-2779. doi: 10.1016/j.arthro.2021.04.008. Epub 2021 Apr 20.
• Cho NS, Yi JW, Rhee YG. Arthroscopic biceps augmentation for avoiding undue tension in repair of massive rotator cuff tears. Arthroscopy. 2009 Feb;25(2):183-91. doi: 10.1016/j.arthro.2008.09.012. Epub 2008 Nov 1.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2022
• Primary Completion (Actual): April 14, 2025
• Study Completion (Actual): April 14, 2025

Study Registration Dates

• First Submitted: October 11, 2024
• First Submitted That Met QC Criteria: October 28, 2024
• First Posted (Actual): October 29, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: rotator cuff; tendon transfer; biceps reinforcement; biceps autograft
• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 53239121.4.0000.5259

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