Self-locking Tenodesis of the Long Chief of the Biceps Vs. Lasso 360 Tenodesis in Arthroscopic Rotator Cuff Repair Rotator Cuff Repair

Not Applicable

Recruiting

• Conditions: Rotator Cuff Injury

• Registration Number: NCT06774820
• Lead Sponsor: Clinique Générale dAnnecy

Brief Summary

The aim of this study is to compare the clinical results and complications of self-locking biceps tenodesis and double 360 lasso loop biceps tenodesis for the treatment of long chief of biceps or superior labrum anterior-posterior (SLAP) tendon pathology during shoulder arthroscopy in patients undergoing arthroscopic rotator cuff repair. 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. 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. Given its potential advantages, self-locking biceps tenodesis could emerge as 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 to choose the most appropriate treatment for their patients suffering from long biceps tendon pathology.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-09
• Study First Posted: 2025-01-14
• Study Start: 2025-01-22
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12
• Primary Completion: 2027-11-15
• Study Completion: 2028-01-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Full-thickness rotator cuff tear of the supraspinatus/infraspinatus tendon, diagnosed preoperatively by ultrasound, arthro-CT or MRI.
• Patients must be able to read and write in French in order to complete the questionnaires and sign the informed consent form.

Exclusion Criteria

• Partial rotator cuff tear
• Massive and irreparable rotator cuff tear
• Grade 4 according to Goutallier classification of fatty degeneration of rotator cuff muscles
• Rupture of the long biceps
• Hourglass deformity of biceps tendon origin
• 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, defined by Hamada classification as grade 2 or higher.
• Previous shoulder surgery.
• Dementia or inability to complete questionnaires and assessments.
• Pregnant, parturient or breast-feeding patients.
• Persons under legal protection (curatorship, guardianship, safeguard of justice).
• Persons deprived of their liberty by judicial or administrative measure
• Persons under psychiatric care
• Persons not affiliated to a social security scheme

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Constant score (CMS)	1 year after surgery	The CMS is a 100-point scale comprising four components, including a patient-reported section (pain 15 points and activity level 20 points), for a total of 35 points. Alongside this, there is a doctor-reported section (shoulder strength 25 points, range of motion 40 points) for a total of 65 points.

Secondary Outcome Measures

Name	Time	Method
American Shoulder and Elbow Surgeons Score	3 months, 6 months, 1 year after surgery	The ASES is a 100-point scale comprising 2 assessment dimensions: pain and activities of daily living.

Trial Locations

Locations (1)

Clinique Générale; 🇫🇷 Annecy, France