Rotator Cuff Tears Treated With Long Head of the Biceps Reinforcement

Hospital Universitario Pedro Ernesto

Status: Completed

Conditions: Biceps Tendon Reattachment; Rotator Cuff Injuries

Treatments: Procedure: complete repair without reinforcement; Procedure: LHB tendon reinforcement

Study type: Interventional

Funder types: Other

Identifiers

NCT06664645

53239121.4.0000.5259

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

complete repair with LHB tendon reinforcement

Experimental group

Description:

complete repair with LHB tendon reinforcement

Treatment:

Procedure: LHB tendon reinforcement

complete repair without reinforcement

Active Comparator group

Description:

complete repair without reinforcement.

Treatment:

Procedure: complete repair without reinforcement