Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
ID06774820

Self-locking Tenodesis vs. Lasso 360 Tenodesis in Arthroscopic Rotator Cuff Repair

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

100

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare the outcomes and complications of two surgical techniques—self-locking biceps tenodesis and double 360 lasso loop biceps tenodesis—for treating long head of biceps or superior labrum anterior-posterior (SLAP) tendon problems during shoulder arthroscopy in patients undergoing rotator cuff repair. There is currently no clear evidence favoring tenodesis or tenotomy for this condition, and the study evaluates a new technique called autobloc tenodesis developed at Clinique Générale, which may offer potential benefits such as reducing the occurrence of Popeye deformity. Participants will be randomly assigned to receive either the self-blocking tenodesis procedure or the arthroscopic tenodesis technique during their shoulder surgery. Both procedures involve detaching the long head of the biceps tendon from its origin and securing it in the bicipital groove, with a radiographically visible suture attached to the tendon to aid imaging. The study includes a single-blind design and focuses on comparing these two surgical approaches. During the study, participants' shoulder function and outcomes will be assessed using the Constant score (CMS) at one year after surgery and the American Shoulder and Elbow Surgeons Score at 3 months, 6 months, and 1 year post-surgery. Patients must be able to complete questionnaires in French, and the study excludes those with certain shoulder conditions or prior surgeries. The trial is set to begin in 2025 and continue through 2028, with thorough monitoring of clinical results and complications throughout the follow-up period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Full-thickness rotator cuff tear of the supraspinatus or infraspinatus tendon confirmed by ultrasound, arthro-CT, or MRI
  • Patients able to read and write in French to complete questionnaires and provide informed consent
  • Age 40 years or older
Not Eligible

You will not qualify if you...

  • Partial rotator cuff tear
  • Massive and irreparable rotator cuff tear
  • Grade 4 fatty degeneration of rotator cuff muscles by Goutallier classification
  • Rupture of the long biceps tendon
  • Hourglass deformity of biceps tendon origin
  • Osteoarthritis of the glenohumeral joint shown by X-ray
  • Acromion to humeral head distance 6 mm or less (Hamada grade 2 or higher)
  • Previous shoulder surgery
  • Dementia or inability to complete questionnaires and assessments
  • Pregnant, parturient, or breast-feeding
  • Under legal protection or deprived of liberty by judicial/administrative measure
  • Under psychiatric care
  • Not affiliated with a social security scheme

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - 1 day

Participants undergo arthroscopic rotator cuff repair with either self-locking tenodesis or lasso 360 tenodesis of the long head of the biceps tendon.

1 surgery visit

Post-operative Follow-up

Duration - 1 year

Participants are followed to assess recovery and shoulder function after surgery.

Follow-up visits at 3 months, 6 months, and 1 year after surgery

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

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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Published Research Related To This Trial

Biceps lasso loop and self-locking tenodesis alongside repair of rotator cuff tears: randomised controlled trial study protocol (BLAST 1).

Igor J Shirinskiy, Dries Boulidam, Arno A Macken...

https://pubmed.ncbi.nlm.nih.gov/41263857