Treatment of the Biceps With Concomitant Supraspinatus Tears

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Supraspinatus Tear

Intervention / Treatment
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* Procedure: LHB Tenotomy
* Procedure: LHB Tenodesis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Leaving LHB Intact<br>The long head of the biceps (LHB) will be left intact. | |
| Experimental: LHB tenotomy<br>The long head of the biceps (LHB) will be cut at its origin. | Procedure: LHB Tenotomy<br>* Will be performed arthroscopically by cutting the LHB at its origin with arthroscopic scissors<br>|
| Experimental: LHB Tenodesis<br>The long head of the biceps (LHB) will be cut at its origin and reattached. | Procedure: LHB Tenodesis<br>* ill be performed arthroscopically with a tenodesis at the top of the articular margin using an onlay technique.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASES score | American Shoulder and Elbow Surgeon (ASES) score. From 0 (worst) to 100 (best). | At 24 post-operative months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS pain | Visual analog scale (VAS) pain. From 0 (best) to 10 (worst) | At 24 post-operative months | 
| SSV | Subjective Shoulder Value (SSV). From 0 (worst) to 100 (best). | At 24 post-operative months | 
| LHB score | Long head of the biceps (LHB) score. From 0 (worst) to 100 (best). | At 24 post-operative months | 
| AFF | Anterior Forward Flexion. In degrees. Will be performed with a goniometer by an independent investigator | At 24 post-operative months | 
| ER at side | External Rotation at the side. In degrees. Will be performed with a goniometer by an independent investigator | At 24 post-operative months | 
| IR | Internal Rotation to nearest spinal level. Will be performed with a goniometer by an independent investigator | At 24 post-operative months | 
| Complications | Any type of post-operative complication | Within 2 postoperative years | 
| Patient satisfaction | Yes or no | At 24 post-operative months | 
| Location of the defect (at the foot print | medial cuff failure) | Radiographic outcome evaluated using an ultrasound examination. | At 6 post-operative month | 
| Status of the biceps tendon (intact | in continuity | defect) | Radiographic outcome evaluated using an ultrasound examination. | At 6 post-operative month | 
| Signs of anchor displacement and location (lateral | medial row). | Radiographic outcome evaluated using an ultrasound examination. | At 6 post-operative month | 
| Tendon thickness | Radiographic outcome evaluated using an ultrasound examination. | At 6 post-operative month | 
| Number of patients with bursitis | Radiographic outcome evaluated using an ultrasound examination. | At 6 post-operative month | 
| Number of patients with healing of the Supraspinatus tear according to Sugaya classification | Radiographic outcome evaluated using an ultrasound examination. | At 6 post-operative month | 
| Number of patients with liquid in the bicipital sheath | Radiographic outcome evaluated using an ultrasound examination. | At 6 post-operative month | 
| Number of patients with hypervascularization of the sheath | Radiographic outcome evaluated using an ultrasound examination. | At 6 post-operative month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Long head of the biceps, Supraspinatus tear, tenotomy, tenodesis, rotator cuff repair