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Biceps Tenodesis with 360 Suture Anchor Versus Self Locking Tenodesis in the Absence of Rotator Cuff Tears (Blast2)

C

Clinique Générale dAnnecy

Status

Enrolling

Conditions

SLAP Lesion

Treatments

Procedure: self-locking biceps tenodesis
Procedure: Biceps Tenodesis with 360 Suture anchor

Study type

Interventional

Funder types

Other

Identifiers

NCT06772103
2024-43-CGA

Details and patient eligibility

About

This is a prospective randomized controlled trial. The aim of this study is to compare the clinical results and complications of self-locking biceps tenodesis and double-loop 360 lasso biceps tenodesis for the treatment of pathology of the long head of the biceps or superior labrum anterior-posterior (SLAP) during shoulder arthroscopy in patients without arthroscopic rotator cuff tears. Currently, there is no consensus on the use of tenodesis versus tenotomy to treat pathology of the long head of the biceps during arthroscopic rotator cuff repair. Numerous studies have examined the clinical results of long biceps tenotomy versus long biceps tenodesis, and there is no evidence to date of superiority of either technique. However, these studies were carried out on patients with rotator cuff tears, and so it has not been possible to directly compare the two procedures. At Clinique Générale, we use a new, innovative technique called autobloc tenodesis to treat pathologies of the long head of the biceps. There are no comparative studies between autobloc tenodesis of the biceps and biceps tenodesis in patients without rotator cuff tears. Given its potential advantages, autobloc biceps tenodesis could become the new technique of choice for treating biceps longus tendon pathology, potentially reducing differences in outcomes such as Popeye deformity. The information provided by this study could potentially guide future clinical practice, helping surgeons choose the most appropriate treatment for their patients with long biceps tendon pathology.

Enrollment

100 estimated patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Tendinopathy of the Long Head of the Biceps based on clinical symptoms or SLAP-type lesion
  • Partial thickness rupture or absence of rupture of the rotator cuff of the subscapular, supraspinatus and/or infraspinatus tendons, diagnosed preoperatively on ultrasound, arthro-CT or MRI.

Exclusion criteria

  • Osteoarthritis of the glenohumeral joint, defined by narrowing of the glenohumeral joint space or osteophytes, using AP radiography of the affected shoulder.
  • Distance between acromion and humeral head measuring 6 mm or less
  • Previous shoulder surgery.
  • Dementia or inability to complete questionnaires and assessments.
  • Pregnant or breast-feeding patient
  • Protected adult patient
  • Patient not covered by social security.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

self-locking biceps tenodesis
Experimental group
Treatment:
Procedure: self-locking biceps tenodesis
360° double-loop lasso biceps tenodesis
Active Comparator group
Treatment:
Procedure: Biceps Tenodesis with 360 Suture anchor

Trial contacts and locations

1

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Central trial contact

Geert Alexander Buijze, MD

Data sourced from clinicaltrials.gov

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