Actively Recruiting

Phase Not Applicable
Age: 40Years - 80Years
All Genders
NCT06772103

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

Led by Clinique Générale dAnnecy · Updated on 2025-02-12

100

Participants Needed

1

Research Sites

161 weeks

Total Duration

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AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Age between 40 and 80 years
Not Eligible

You will not qualify if you...

  • Osteoarthritis of the glenohumeral joint shown by joint space narrowing or osteophytes on shoulder X-ray
  • 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
  • Protected adult patient
  • Not covered by social security

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Clinique Générale

Annecy, France, 74000

Actively Recruiting

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Research Team

G

Geert Alexander Buijze, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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