Tenotomy Versus no Tenotomy LHB in Rotator Cuff Repair

NCT07289334 | Completed

• 1 other identifier: 02-14-105-018
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Constant Murley

  100-point standardized tool for assessing shoulder function, comprising four domains Pain (0-15 points) daily life activity (0-20 points) range of motion (0-40 points) strenght (0-25 points) 0 (the worst) - 100 (the best)

  24 month

Secondary Outcomes (2)

• ASES

  24 MONTHS

• cross sectional area of the LHBT

  24 months

Study Arms (2)

NO TENOTOMY

PLACEBO COMPARATOR

NO TENOTOMY OF LHBT + ROTATOR CUFF REPAIR

Procedure: ROTATOR CUFF REPAIR

TENOTOMY

EXPERIMENTAL

TENOTOMY OF LHBT + ROTATOR CUFF REPAIR

Procedure: ROTATOR CUFF REPAIR

Interventions

ROTATOR CUFF REPAIR PROCEDURE

ROTATOR CUFF REPAIR

NO TENOTOMY; TENOTOMY

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Consorci Sanitari de Terrassa: lead

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgeon of Shoulder Unit, Consorci Sanitari de Terrassa

Model Details: Patients were randomly assigned to two groups, TENOTOMY (n=25) and NO TENOTOMY (n=29), using a centralized random number program.

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: December 17, 2025
• Study Start: January 1, 2015
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: December 17, 2025

Record last verified: 2025-12