Rotator Cuff Tears Treated With Long Head of the Biceps Reinforcement

NCT06664645 | Completed

• 1 other identifier: 53239121.4.0000.5259
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rotator Cuff Injuries; Biceps Tendon Reattachment

Keywords

rotator cuff; tendon transfer; biceps reinforcement; biceps autograft

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

complete repair with LHB tendon reinforcement

EXPERIMENTAL

complete repair with LHB tendon reinforcement

Procedure: LHB tendon reinforcement

complete repair without reinforcement

ACTIVE COMPARATOR

complete repair without reinforcement.

Procedure: complete repair without reinforcement

Interventions

LHB tendon reinforcement PROCEDURE

complete repair with LHB tendon reinforcement

complete repair with LHB tendon reinforcement

complete repair without reinforcement PROCEDURE

conventional rotator cuff complete repair without reinforcement

complete repair without reinforcement

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Pedro Ernesto: lead

Study Sites (1)

hospital Universitário Pedro Ernesto

Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil

Location

Related Publications (3)

• 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.

  PMID: 32267730 BACKGROUND

• 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.

  PMID: 33892075 BACKGROUND

• 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.

  PMID: 19171279 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 29, 2024
• Study Start: January 14, 2022
• Primary Completion: April 14, 2025
• Study Completion: April 14, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)