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Search / Trial NCT06774820

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

Launched by CLINIQUE GÉNÉRALE DANNECY · Jan 9, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Rotator Cuff Biceps Long Biceps Tendon

ClinConnect Summary

This clinical trial is studying two different surgical techniques for treating injuries to a specific part of the shoulder called the long head of the biceps. The goal is to see which method—self-locking biceps tenodesis or double lasso loop biceps tenodesis—provides better results and has fewer complications for patients undergoing rotator cuff repair surgery. This research is important because there hasn't been a clear answer on which technique works best, and it could help doctors make better treatment decisions for their patients in the future.

To be eligible for this study, participants must have a full-thickness tear in the rotator cuff, which is diagnosed using imaging tests like ultrasound or MRI. They should also be able to read and write in French to complete required forms. Participants will undergo an arthroscopic shoulder surgery and will be monitored to compare the outcomes of the two techniques. This trial is currently recruiting patients, and it aims to provide valuable insights that could enhance shoulder surgery practices.

Gender

ALL

Eligibility criteria

  • 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

About Clinique Générale Dannecy

Clinique Générale d'Annecy is a leading healthcare institution dedicated to advancing medical research and improving patient outcomes through innovative clinical trials. With a commitment to excellence, the clinic combines state-of-the-art facilities with a multidisciplinary team of experienced professionals who specialize in various therapeutic areas. By fostering collaborations with pharmaceutical companies and research organizations, Clinique Générale d'Annecy aims to facilitate the development of new treatments and therapies, ensuring rigorous adherence to ethical standards and regulatory guidelines. Their focus on patient-centered care and scientific integrity positions them as a key player in the clinical research landscape.

Locations

Annecy, , France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported