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Tenotomy Versus no Tenotomy LHB in Rotator Cuff Repair

C

Consorci Sanitari de Terrassa

Status

Completed

Conditions

Long Head of Biceps Brachii Lesions
Rotator Cuff Tears

Treatments

Procedure: ROTATOR CUFF REPAIR

Study type

Interventional

Funder types

Other

Identifiers

NCT07289334
02-14-105-018

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups, including a placebo group

NO TENOTOMY
Placebo Comparator group
Description:
NO TENOTOMY OF LHBT + ROTATOR CUFF REPAIR
Treatment:
Procedure: ROTATOR CUFF REPAIR
TENOTOMY
Experimental group
Description:
TENOTOMY OF LHBT + ROTATOR CUFF REPAIR
Treatment:
Procedure: ROTATOR CUFF REPAIR

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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