Tenotomy Versus no Tenotomy LHB in Rotator Cuff Repair

NCT ID: NCT07289334

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2017-06-30

Brief Summary

The function of the long head of the biceps tendon (LHBT) in the glenohumeral joint generates controversy among researchers. For some, the tendon does not have a significant function in the shoulder, while others consider it acts as a depressor of the humeral head and a stabilizer of the joint. These functions may be enhanced in cases of rotator cuff injuries, where compensatory hypertrophy and/or instability of the LHBT can occur, which can also be a source of pain. One of the imaging techniques used for diagnosing these injuries is ultrasound.

Initially, G. Walch proposed tenotomy of the LHBT in massive rotator cuff tears to improve pain and, in some cases, shoulder function. Currently, many authors advocate tenotomy of the LHBT as an adjunct to rotator cuff repair to avoid postoperative pain. However, there is no evidence that this procedure improves the clinical outcomes of isolated rotator cuff repair.

Based on the pathophysiology of the LHBT associated with rotator cuff injuries and the current trend to perform tenotomies in conjunction with cuff repair, the objectives of this doctoral thesis project were:

To compare the clinical and imaging outcomes of arthroscopic rotator cuff repairs with and without LHBT tenotomy.

To analyze the position and cross-sectional area of the LHBT in the bicipital groove using ultrasound in cases with and without tenotomy.

Conditions

Long Head of Biceps Brachii Lesions; Rotator Cuff Tears

Keywords

long head biceps; rotator cuff tears; tenotomy; no tenotomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

NO TENOTOMY

NO TENOTOMY OF LHBT + ROTATOR CUFF REPAIR

Group Type: PLACEBO_COMPARATOR

ROTATOR CUFF REPAIR

Intervention Type: PROCEDURE

ROTATOR CUFF REPAIR

TENOTOMY

TENOTOMY OF LHBT + ROTATOR CUFF REPAIR

Group Type: EXPERIMENTAL

ROTATOR CUFF REPAIR

Intervention Type: PROCEDURE

ROTATOR CUFF REPAIR

Interventions

ROTATOR CUFF REPAIR

ROTATOR CUFF REPAIR

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age between 40 and 65 years
• Partial supraspinatus tears (≥ 50% thickness)
• Complete supraspinatus tears ≤ 3 cm in the coronal plane
• Muscle atrophy less than stage 2 according to Thomazeau
• Presence of the LHBT in the bicipital groove

Exclusion Criteria

• Patients younger than 40 or older than 65 years
• LHBT rupture
• Partial supraspinatus tears < 50% thickness
• Supraspinatus tears > 3 cm
• Tears of other rotator cuff tendons, with or without supraspinatus involvement
• Traumatic tears with surgery performed less than 3 months after injury
• Muscle atrophy ≥ stage 2 Thomazeau
• Associated degenerative glenohumeral pathology (> Samilson 1)
• Previous shoulder surgeries
• Previous shoulder infections
• Associated peripheral neurological injuries
• Degenerative neurological conditions
• Patients who refused to sign informed consent

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Consorci Sanitari de Terrassa

OTHER

Sponsor Role: lead

Responsible Party

Josep Maria Mora Guix

Surgeon of Shoulder Unit, Consorci Sanitari de Terrassa

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

02-14-105-018

Identifier Type: -

Identifier Source: org_study_id