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Rotator Cuff Tears Treated With Long Head of the Biceps Reinforcement

NCT06664645 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-06-26

No results posted yet for this study

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

Interventions

PROCEDURE

LHB tendon reinforcement

complete repair with LHB tendon reinforcement

PROCEDURE

complete repair without reinforcement

conventional rotator cuff complete repair without reinforcement

Sponsors & Collaborators

  • Hospital Universitario Pedro Ernesto

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-14
Primary Completion
2025-04-14
Completion
2025-04-14

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06664645 on ClinicalTrials.gov