Treatment of the Biceps With Concomitant Supraspinatus Tears

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
La Tour Hospital
Study ID
NCT05660031
Status
Recruiting

Conditions

  • Supraspinatus Tear

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • LHB Tenotomy — PROCEDURE
    Will be performed arthroscopically by cutting the LHB at its origin with arthroscopic scissors
  • LHB Tenodesis — PROCEDURE
    "ill be performed arthroscopically with a tenodesis at the top of the articular margin using an onlay technique.

Study Details

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.

Key Dates

Start date
Jun 1, 2021
Status verified
Apr 2025
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

ASES score [ Time Frame: At 24 post-operative months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Sports Medicine and Shoulder Surgery, University of MichiganAnn ArborMichigan48109
Asheesh Bedi, MD
Oregon Health & Science UniversityPortlandOregon97239
Patrick Denard, MD

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