NCT05660031

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Jun 2021

Longer than P75 for not_applicable

Geographic Reach
3 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress99%
Jun 2021Jun 2026

Study Start

First participant enrolled

June 1, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

5 years

First QC Date

December 4, 2022

Last Update Submit

April 23, 2025

Conditions

Supraspinatus Tear

Keywords

Long head of the bicepsSupraspinatus teartenotomytenodesisrotator cuff repair

Outcome Measures

Primary Outcomes (1)

  • ASES score

    American Shoulder and Elbow Surgeon (ASES) score. From 0 (worst) to 100 (best).

    At 24 post-operative months

Secondary Outcomes (16)

  • VAS pain

    At 24 post-operative months

  • SSV

    At 24 post-operative months

  • LHB score

    At 24 post-operative months

  • AFF

    At 24 post-operative months

  • ER at side

    At 24 post-operative months

  • +11 more secondary outcomes

Study Arms (3)

Leaving LHB Intact

NO INTERVENTION

The long head of the biceps (LHB) will be left intact.

LHB tenotomy

EXPERIMENTAL

The long head of the biceps (LHB) will be cut at its origin.

Procedure: LHB Tenotomy

LHB Tenodesis

EXPERIMENTAL

The long head of the biceps (LHB) will be cut at its origin and reattached.

Procedure: LHB Tenodesis

Interventions

LHB TenotomyPROCEDURE

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

LHB tenotomy
LHB TenodesisPROCEDURE

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

LHB Tenodesis

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Sports Medicine and Shoulder Surgery, University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

Group 23 Sports Medicine

Calgary, Alberta, T3B 6B7, Canada

RECRUITING

la Tour hospital

Meyrin, Canton of Geneva, 1217, Switzerland

RECRUITING

Study Officials

  • Alexandre Lädermann, MD

    La Tour Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Lädermann, MD

CONTACT

+41 22 71 975 55alexandre.laedermann@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedic Surgeon FMH, Shoulder and Elbow Surgery Traumatology

Study Record Dates

First Submitted

December 4, 2022

First Posted

December 21, 2022

Study Start

June 1, 2021

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

April 25, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)US(2)CA(1)