RecruitingNot ApplicableNCT05660031

Treatment of the Biceps With Concomitant Supraspinatus Tears

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


Sponsor

La Tour Hospital

Enrollment

180 participants

Start Date

Jun 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 50 YearsMax Age: 80 Years

Inclusion Criteria5

  • 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

Exclusion Criteria7

  • 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

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Interventions

PROCEDURELHB Tenotomy

Will be performed arthroscopically by cutting the LHB at its origin with arthroscopic scissors

PROCEDURELHB Tenodesis

"ill be performed arthroscopically with a tenodesis at the top of the articular margin using an onlay technique.


Locations(4)

Sports Medicine and Shoulder Surgery, University of Michigan

Ann Arbor, Michigan, United States

Oregon Health & Science University

Portland, Oregon, United States

Group 23 Sports Medicine

Calgary, Alberta, Canada

la Tour hospital

Meyrin, Canton of Geneva, Switzerland

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NCT05660031


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