Actively Recruiting

Phase Not Applicable
Age: 50Years - 80Years
All Genders
NCT05660031

Treatment of the Biceps With Concomitant Supraspinatus Tears

Led by La Tour Hospital · Updated on 2025-04-25

180

Participants Needed

4

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The long head of the biceps (LHB) tendon is thought to be a common source of shoulder pain and dysfunction in patients with rotator cuff pathology. Tenotomy and tenodesis have been shown to produce favourable and comparable results in treating LHB lesions, but a controversy still exists regarding the treatment of choice. Some suggest that tenotomy should be reserved for older, low-demand patients, while tenodesis should be performed in younger patients and those who engage in heavy labor. Proponents of tenotomy suggest that this is a technically easy procedure that leads to easy rehabilitation and fast return to activity with a low complication and reoperation rate. However, those who support LHB tenodesis list good preservation of elbow flexion and supination strength, improvement of functional scores, elimination of pain, and avoidance of cosmetic deformity as benefits of the procedure. Alternatively, the LHB can be maintained in the joint without tenodesis or tenotomy. In fact, it has not been clearly shown that LHB tenodesis or tenotomy leads to improved outcomes compared to leaving the biceps tendon intact.

CONDITIONS

Official Title

Treatment of the Biceps With Concomitant Supraspinatus Tears

Who Can Participate

Age: 50Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy.
  • Full thickness tear of the supraspinatus tendon
  • Intact subscapularis tendon
  • Primary rotator cuff repair
  • Age 50-80
Not Eligible

You will not qualify if you...

  • Previous full thickness biceps tear
  • Infection and neuropathic joints
  • Known or suspected non-compliance, drug or alcohol abuse
  • Patients incapable of judgement or under tutelage
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for MRI scan etc.
  • Enrolment of the investigator, his/her family members, employees and other dependent persons
  • Patient declines to participate in study

AI-Screening

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Trial Site Locations

Total: 4 locations

1

Sports Medicine and Shoulder Surgery, University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

2

Oregon Health & Science University

Portland, Oregon, United States, 97239

Actively Recruiting

3

Group 23 Sports Medicine

Calgary, Alberta, Canada, T3B 6B7

Actively Recruiting

4

la Tour hospital

Meyrin, Canton of Geneva, Switzerland, 1217

Actively Recruiting

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Research Team

A

Alexandre Lädermann, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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