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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| LHB Tenodesis | Experimental | The long head of the biceps (LHB) will be cut at its origin and reattached. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LHB Tenotomy | Procedure | Will be performed arthroscopically by cutting the LHB at its origin with arthroscopic scissors |
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| Measure | Description | Time Frame |
|---|---|---|
| ASES score | American Shoulder and Elbow Surgeon (ASES) score. From 0 (worst) to 100 (best). | At 24 post-operative months |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandre Lädermann, MD | Contact | +41 22 71 975 55 | alexandre.laedermann@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Alexandre Lädermann, MD | La Tour Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sports Medicine and Shoulder Surgery, University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| LHB Tenodesis | Procedure | "ill be performed arthroscopically with a tenodesis at the top of the articular margin using an onlay technique. |
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| 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 |
| Oregon Health & Science University | Recruiting | Portland | Oregon | 97239 | United States |
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| Group 23 Sports Medicine | Recruiting | Calgary | Alberta | T3B 6B7 | Canada |
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| la Tour hospital | Recruiting | Meyrin | Canton of Geneva | 1217 | Switzerland |
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