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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
Michigan
Sports Medicine and Shoulder Surgery, University of Michigan
RECRUITING
Ann Arbor
Oregon
Oregon Health & Science University
RECRUITING
Portland
Other Locations
Canada
Group 23 Sports Medicine
RECRUITING
Calgary
Switzerland
la Tour hospital
RECRUITING
Meyrin
Contact Information
Primary
Alexandre Lädermann, MD
alexandre.laedermann@gmail.com
+41 22 71 975 55
Time Frame
Start Date: 2021-06-01
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 180
Treatments
No_intervention: Leaving LHB Intact
The long head of the biceps (LHB) will be left intact.
Experimental: LHB tenotomy
The long head of the biceps (LHB) will be cut at its origin.
Experimental: LHB Tenodesis
The long head of the biceps (LHB) will be cut at its origin and reattached.
Related Therapeutic Areas
Sponsors
Leads: La Tour Hospital

This content was sourced from clinicaltrials.gov