Treatment of the Biceps With Concomitant Supraspinatus Tears
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Leaving LHB Intact The long head of the biceps (LHB) will be left intact. |
|
| Experimental: LHB tenotomy The long head of the biceps (LHB) will be cut at its origin. |
Procedure: LHB Tenotomy
Will be performed arthroscopically by cutting the LHB at its origin with arthroscopic scissors
|
| Experimental: LHB Tenodesis The long head of the biceps (LHB) will be cut at its origin and reattached. |
Procedure: LHB Tenodesis
"ill be performed arthroscopically with a tenodesis at the top of the articular margin using an onlay technique.
|
Outcome Measures
Primary Outcome Measures
- ASES score [At 24 post-operative months]
American Shoulder and Elbow Surgeon (ASES) score. From 0 (worst) to 100 (best).
Secondary Outcome Measures
- VAS pain [At 24 post-operative months]
Visual analog scale (VAS) pain. From 0 (best) to 10 (worst)
- SSV [At 24 post-operative months]
Subjective Shoulder Value (SSV). From 0 (worst) to 100 (best).
- LHB score [At 24 post-operative months]
Long head of the biceps (LHB) score. From 0 (worst) to 100 (best).
- AFF [At 24 post-operative months]
Anterior Forward Flexion. In degrees. Will be performed with a goniometer by an independent investigator
- ER at side [At 24 post-operative months]
External Rotation at the side. In degrees. Will be performed with a goniometer by an independent investigator
- IR [At 24 post-operative months]
Internal Rotation to nearest spinal level. Will be performed with a goniometer by an independent investigator
- Complications [Within 2 postoperative years]
Any type of post-operative complication
- Patient satisfaction [At 24 post-operative months]
Yes or no
- Location of the defect (at the foot print | medial cuff failure) [At 6 post-operative month]
Radiographic outcome evaluated using an ultrasound examination.
- Status of the biceps tendon (intact | in continuity | defect) [At 6 post-operative month]
Radiographic outcome evaluated using an ultrasound examination.
- Signs of anchor displacement and location (lateral | medial row). [At 6 post-operative month]
Radiographic outcome evaluated using an ultrasound examination.
- Tendon thickness [At 6 post-operative month]
Radiographic outcome evaluated using an ultrasound examination.
- Number of patients with bursitis [At 6 post-operative month]
Radiographic outcome evaluated using an ultrasound examination.
- Number of patients with healing of the Supraspinatus tear according to Sugaya classification [At 6 post-operative month]
Radiographic outcome evaluated using an ultrasound examination.
- Number of patients with liquid in the bicipital sheath [At 6 post-operative month]
Radiographic outcome evaluated using an ultrasound examination.
- Number of patients with hypervascularization of the sheath [At 6 post-operative month]
Radiographic outcome evaluated using an ultrasound examination.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Full thickness tear of the supraspinatus tendon
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Intact subscapularis tendon
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Primary rotator cuff repair
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Age 50-80
Exclusion Criteria:
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Previous full thickness biceps tear
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Infection and neuropathic joints
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Known or suspected non-compliance, drug or alcohol abuse
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Patients incapable of judgement or under tutelage
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Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for MRI scan etc.
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Enrolment of the investigator, his/her family members, employees and other dependent persons
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Patient declines to participate in study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sports Medicine and Shoulder Surgery, University of Michigan | Ann Arbor | Michigan | United States | 48109 |
| 2 | Oregon Health & Science University | Portland | Oregon | United States | 97239 |
| 3 | Group 23 Sports Medicine | Calgary | Alberta | Canada | T3B 6B7 |
| 4 | la Tour hospital | Meyrin | Geneva | Switzerland | 1217 |
Sponsors and Collaborators
- La Tour Hospital
Investigators
- Principal Investigator: Alexandre Lädermann, MD, La Tour Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-00066