Clinical trial NCT06772103: Biceps Tenodesis with 360 Suture Anchor Versus Self Locking Tenodesis in the Absence of Rotator Cuff Tears
Official title: Biceps Tenodesis with 360 Suture Anchor Versus Self Locking Tenodesis in the Absence of Rotator Cuff Tears
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: SLAP Lesion
Keywords: biceps
tenodesis
imaging
tendon repair
Lead sponsor: Clinique Générale dAnnecy
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Constant score
timeFrame: 1 year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Annecy
country: France
facility: Clinique Générale
Study officials:
References: