RECRUITING

Treatment of the Biceps With Concomitant Supraspinatus Tears

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-06-01
Study Completion:2025-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05660031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Full thickness tear of the supraspinatus tendon
  3. * Intact subscapularis tendon
  4. * Primary rotator cuff repair
  5. * Age 50-80
  1. * Previous full thickness biceps tear
  2. * Infection and neuropathic joints
  3. * Known or suspected non-compliance, drug or alcohol abuse
  4. * Patients incapable of judgement or under tutelage
  5. * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for MRI scan etc.
  6. * Enrolment of the investigator, his/her family members, employees and other dependent persons
  7. * Patient declines to participate in study

Contacts and Locations

Study Contact

Alexandre Lädermann, MD
CONTACT
+41 22 71 975 55
alexandre.laedermann@gmail.com

Principal Investigator

Alexandre Lädermann, MD
PRINCIPAL_INVESTIGATOR
La Tour Hospital

Study Locations (Sites)

Sports Medicine and Shoulder Surgery, University of Michigan
Ann Arbor, Michigan, 48109
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States

Collaborators and Investigators

Sponsor: La Tour Hospital

  • Alexandre Lädermann, MD, PRINCIPAL_INVESTIGATOR, La Tour Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-01
Study Completion Date2025-06-01

Study Record Updates

Study Start Date2021-06-01
Study Completion Date2025-06-01

Terms related to this study

Keywords Provided by Researchers

  • Long head of the biceps
  • Supraspinatus tear
  • tenotomy
  • tenodesis
  • rotator cuff repair

Additional Relevant MeSH Terms

  • Supraspinatus Tear