Clinical trial NCT06664645: Rotator Cuff Tears Treated with Long Head of the Biceps Reinforcement
Official title: Evaluation of Rotator Cuff Repair with Long Head of the Biceps Reinforcement: a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Injuries
Biceps Tendon Reattachment
Keywords: rotator cuff
tendon transfer
biceps reinforcement
biceps autograft
Lead sponsor: Hospital Universitario Pedro Ernesto
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual analogue score (VAS)
timeFrame: 24 months
measure: Structural outcomes
timeFrame: 24 months
measure: American Shoulder and Elbow Score (ASES)
timeFrame: 24
measure: The University of California-Los Angeles (UCLA)
timeFrame: 24 months
measure: The 12 item Short Form Survey (SF-12)
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: hospital Universitário Pedro Ernesto
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.