NCT06664645

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Hospital Universitario Pedro Ernesto · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Rotator Cuff Injuries
• Biceps Tendon Reattachment

Interventions

Type	Name	Description
PROCEDURE	LHB tendon reinforcement	complete repair with LHB tendon reinforcement
PROCEDURE	complete repair without reinforcement	conventional rotator cuff complete repair without reinforcement

Timeline

• Start date: 2022-01-14
• Primary completion: 2025-04-14
• Completion: 2025-04-14
• First posted: 2024-10-29
• Last updated: 2025-06-26

Locations

1 site across 1 country: Brazil