Recruiting

Biceps with Supraspinatus

Sponsor:

La Tour Hospital

Code:

NCT05660031

Conditions

Supraspinatus Tear

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

LHB Tenotomy

LHB Tenodesis

Study Details

Brief 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.

Conditions

Supraspinatus Tear

Study ID

NCT05660031

Start date

Jun 1, 2021

Status verified date

Apr, 2025

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

LHB Tenotomy

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

LHB Tenodesis

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Sports Medicine and Shoulder Surgery, University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Asheesh Bedi, MD

asheesh.bedi@gmail.com

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Patrick Denard, MD

pjdenard@gmail.com

Group 23 Sports Medicine

Recruiting

Calgary, Alberta, Canada, T3B 6B7

Contacts

Ian K Lo, MD

ikylo@ucalgary.ca

More Information

Sponsor

La Tour Hospital

Last update posted

Apr 25, 2025

Last verified

Apr, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by La Tour Hospital on 2025-04-25.