Actively Recruiting

Phase Not Applicable
Age: 50Years - 80Years
All Genders
ID05660031

Treatment of the Biceps With Concomitant Supraspinatus Tears: A Multicenter Pragmatic Three-Arm Parallel-Group Randomized Surgical Trial

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

180

Participants Needed

4

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying patients aged 50 to 80 with a full-thickness supraspinatus tendon tear to compare three treatments for the long head of the biceps (LHB) tendon, which may cause shoulder pain and dysfunction in rotator cuff problems. The study aims to find out if LHB tenodesis offers better functional outcomes after surgery compared to LHB tenotomy or leaving the tendon intact. The trial also looks at differences in complications and patient satisfaction among these approaches. Participants will be randomly assigned to one of three groups: leaving the LHB tendon intact, performing an arthroscopic tenotomy where the tendon is cut at its origin, or performing an arthroscopic tenodesis where the tendon is cut and reattached using an onlay technique. All patients will undergo rotator cuff repair surgery. This study is conducted across multiple centers and uses a single-blind design to assess these surgical options. During the study, participants will be evaluated at various times, including 6 months and 24 months after surgery. Assessments include the ASES score, pain levels, shoulder function measures, tendon healing status, and any complications. Patient satisfaction and specific imaging findings related to the tendon and repair site will also be monitored. Follow-up will continue for up to two years to observe long-term outcomes and safety.

CONDITIONS

Brief 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 and can participate in study procedures and follow-up
  • Full thickness tear of the supraspinatus tendon
  • Intact subscapularis tendon
  • Primary rotator cuff repair
  • Age between 50 and 80 years
Not Eligible

You will not qualify if you...

  • Previous full thickness biceps tear
  • Infection or neuropathic joints
  • Known or suspected non-compliance or drug/alcohol abuse
  • Incapable of judgement or under tutelage
  • Unable to follow study procedures due to language, psychological, or other issues
  • Investigator or related persons enrolled
  • Patient declines to participate in study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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 - Surgery day and initial recovery period

Participants undergo rotator cuff repair surgery with one of three approaches to the long head of the biceps tendon: left intact, tenotomy, or tenodesis. Immediate post-operative care follows the surgery.

1 surgery visit and initial post-operative visits

Post-operative Follow-up

Duration - Up to 24 months post-operative

Participants are monitored for functional outcomes, complications, and tendon status over the following months after surgery.

Multiple follow-up visits including assessments at 6 months and 24 months

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

Loading map...

Research Team

A

Alexandre Lädermann, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Similar Trials

Ultrasonic Tenotomy as a Treatment of Partial Rotator Cuff T...

Supraspinatus Tear

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here