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NCT Number: NCT05660031

Treatment of the Biceps With Concomitant Supraspinatus Tears

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.

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Key information

Conditions

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Group 23 Sports Medicine, Calgary, Alberta, Canada

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About this study

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. The primary goal of this prospective multicenter randomized study is to evaluate whether LHB tenodesis grants superior post-operative functional outcomes compared to LHB tenotomy or leaving the LHB intact in patients undergoing rotator cuff repair (RCR) for an isolated full-thickness lesion of the supraspinatus. The primary goal of this prospective multicenter randomized study is to evaluate whether LHB tenodesis grants superior post-operative functional outcomes compared to LHB tenotomy or leaving the LHB intact in patients undergoing rotator cuff repair (RCR) for an isolated full-thickness lesion of the supraspinatus. The secondary goals are to determine whether there is a difference in post-operative functional outcomes between the LHB tenotomy group and the Intact LHB group, and if there is a difference in complication rates or patient satisfaction between the three groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. ASES score

    Time frame: At 24 post-operative months

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

Secondary outcomes

  1. VAS pain

    Time frame: At 24 post-operative months

    Visual analog scale (VAS) pain. From 0 (best) to 10 (worst)

  2. SSV

    Time frame: At 24 post-operative months

    Subjective Shoulder Value (SSV). From 0 (worst) to 100 (best).

  3. LHB score

    Time frame: At 24 post-operative months

    Long head of the biceps (LHB) score. From 0 (worst) to 100 (best).

  4. AFF

    Time frame: At 24 post-operative months

    Anterior Forward Flexion. In degrees. Will be performed with a goniometer by an independent investigator

  5. ER at side

    Time frame: At 24 post-operative months

    External Rotation at the side. In degrees. Will be performed with a goniometer by an independent investigator

  6. IR

    Time frame: At 24 post-operative months

    Internal Rotation to nearest spinal level. Will be performed with a goniometer by an independent investigator

  7. Complications

    Time frame: Within 2 postoperative years

    Any type of post-operative complication

  8. Patient satisfaction

    Time frame: At 24 post-operative months

    Yes or no

  9. Location of the defect (at the foot print | medial cuff failure)

    Time frame: At 6 post-operative month

    Radiographic outcome evaluated using an ultrasound examination.

  10. Status of the biceps tendon (intact | in continuity | defect)

    Time frame: At 6 post-operative month

    Radiographic outcome evaluated using an ultrasound examination.

  11. Signs of anchor displacement and location (lateral | medial row).

    Time frame: At 6 post-operative month

    Radiographic outcome evaluated using an ultrasound examination.

  12. Tendon thickness

    Time frame: At 6 post-operative month

    Radiographic outcome evaluated using an ultrasound examination.

  13. Number of patients with bursitis

    Time frame: At 6 post-operative month

    Radiographic outcome evaluated using an ultrasound examination.

  14. Number of patients with healing of the Supraspinatus tear according to Sugaya classification

    Time frame: At 6 post-operative month

    Radiographic outcome evaluated using an ultrasound examination.

  15. Number of patients with liquid in the bicipital sheath

    Time frame: At 6 post-operative month

    Radiographic outcome evaluated using an ultrasound examination.

  16. Number of patients with hypervascularization of the sheath

    Time frame: At 6 post-operative month

    Radiographic outcome evaluated using an ultrasound examination.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandre Lädermann, MD

CONTACT

[email protected]

+41 22 71 975 55

Sponsors and collaborators

Lead sponsor

La Tour Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Dec 21, 2022
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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