Treatment of the Biceps With Concomitant Supraspinatus Tears

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorLa Tour Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • LHB Tenotomy

    Procedure/Surgery

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

  • LHB Tenodesis

    Procedure/Surgery

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

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: Leaving LHB IntactNo intervention 0 interventions
Group B: LHB tenotomyExperimental treatment 1 intervention
Group C: LHB TenodesisExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ASES score

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

Time frame
At 24 post-operative months

Secondary outcomes

1

VAS pain

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

Time frame
At 24 post-operative months
2

SSV

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

Time frame
At 24 post-operative months
3

LHB score

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

Time frame
At 24 post-operative months
4

AFF

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

Time frame
At 24 post-operative months

Other outcomes

Sponsors and contacts

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