Postoperative Biceps Strength and Electromyographic Activity After Proximal Biceps Tenotomy Versus Tenodesis in Patients With Arthroscopic Rotator Cuff Tear Repair

Study Overview
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Brief Summary
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The most important functions of the biceps brachii muscle are flexion and supination of the elbow. Patients with a partial or complete rotator cuff tear often suffer a lesion of the long head of the biceps tendon (LHBT). The two most common surgical treatments options are tenotomy or tenodesis. This study is to assess the Supination Strength Index (SSI) (the operated side in relation to the healthy side) after proximal biceps tenotomy versus tenodesis.

Detailed Description
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The most important functions of the biceps brachii muscle are flexion and supination of the elbow. Patients with a partial or complete rotator cuff tear often suffer a lesion of the long head of the biceps tendon (LHBT). The two most common surgical treatments options are tenotomy or tenodesis. This study is to assess the Supination Strength Index SSI (the operated side in relation to the healthy side) after proximal biceps tenotomy versus tenodesis.

Official Title
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TenTed-Postoperative Biceps Strength and Electromyographic Activity After Proximal Biceps Tenotomy Versus Tenodesis in Patients With Arthroscopic Rotator Cuff Tear Repair

Conditions
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Biceps Tendon Lesion

Intervention / Treatment
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* Diagnostic Test: Measurement of Muscle strength using a dynamometer
* Diagnostic Test: Range of motion clinical measurement (shoulder and elbow)
* Diagnostic Test: Electromyography (EMG)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient after an arthroscopic rotator cuff repair who underwent a biceps tenotomy or tenodesis 1-4 years postoperative Written informed consent Exclusion Criteria: Inability to provide informed consent Previous biceps injury and or operation Contralateral biceps injury Neurological disorders potentially affecting upper extremity muscle strength.

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tenodesis group<br>Tenodesis as surgical treatment option for a lesion of the long head of the biceps tendon (LHBT) | Diagnostic Test: Measurement of Muscle strength using a dynamometer<br>* Muscle strength will be measured in the elbow bilaterally using a dynamometer (Biodex System 4 Pro: Biodex Medical Systems, Shirley, NY, USA). Supination tests will be performed with the forearm in neutral position, 60° pronation and 60° supination. The elbow will be in 90° flexion, and the shoulder in 45° flexion. Constant pressure is applied to lever of device for 3 to 5 seconds. Maximum torque will be recorded automatically. For each position, three repetitions of 3s (to 5s) contractions will be performed with a break of 15 (or 30s) between the repetitions. There will be an additional break of 2 minutes between measurements of the supination strength in the different positions. This parameter will be analysed regarding asymmetry between both limbs. Isometric endurance of forearm supination will be measured in neutral forearm. Flexion tests will be carried in the same setting as for supination. Flexion tests will be performed with the elbow in 90, 45 and 0° of flexion.<br>Diagnostic Test: Range of motion clinical measurement (shoulder and elbow)<br>* The range of motion parameters (degree) of both shoulders and elbows will be documented. The circumference of the arm will be measured on the line between the medial acromion and the cubital fossa at 1/3 from the cubital fossa<br>Diagnostic Test: Electromyography (EMG)<br>* Electromyographic (EMG) data will be collected using a wireless EMG system (myon AG, Schwarzenberg, Switzerland). Surface electrodes will be placed bilaterally on biceps and triceps following the guidelines of the SENIAM project (Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles)<br>|
| Tenotomy group<br>Tenotomy as surgical treatment option for a lesion of the long head of the biceps tendon (LHBT) | Diagnostic Test: Measurement of Muscle strength using a dynamometer<br>* Muscle strength will be measured in the elbow bilaterally using a dynamometer (Biodex System 4 Pro: Biodex Medical Systems, Shirley, NY, USA). Supination tests will be performed with the forearm in neutral position, 60° pronation and 60° supination. The elbow will be in 90° flexion, and the shoulder in 45° flexion. Constant pressure is applied to lever of device for 3 to 5 seconds. Maximum torque will be recorded automatically. For each position, three repetitions of 3s (to 5s) contractions will be performed with a break of 15 (or 30s) between the repetitions. There will be an additional break of 2 minutes between measurements of the supination strength in the different positions. This parameter will be analysed regarding asymmetry between both limbs. Isometric endurance of forearm supination will be measured in neutral forearm. Flexion tests will be carried in the same setting as for supination. Flexion tests will be performed with the elbow in 90, 45 and 0° of flexion.<br>Diagnostic Test: Range of motion clinical measurement (shoulder and elbow)<br>* The range of motion parameters (degree) of both shoulders and elbows will be documented. The circumference of the arm will be measured on the line between the medial acromion and the cubital fossa at 1/3 from the cubital fossa<br>Diagnostic Test: Electromyography (EMG)<br>* Electromyographic (EMG) data will be collected using a wireless EMG system (myon AG, Schwarzenberg, Switzerland). Surface electrodes will be placed bilaterally on biceps and triceps following the guidelines of the SENIAM project (Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Supination Strength Index SSI | comparison of the Supination Strength Index SSI (the operated side in relation to the healthy side). It is calculated by dividing the strength on the operated side by the strength on the healthy side. | at Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient's pain visual analog scale Score (VAS) | patient's pain visual analog scale score (VAS): 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of no pain at all and worst pain imaginable | at Baseline | 
| American Shoulder and Elbow Surgeons (ASES) Score | The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. The patient questions focus on joint pain, instability, and activities of daily living. Calculation of the ASES score is a complicated process. The final pain score is calculated via an independent formula, while the raw score from the functional questions is multiplied by a coefficient to get the final score for the functional questions. The pain and functional portions are then summed to obtain the final ASES score with higher scores indicating better outcomes | at Baseline | 
| Constant Score | This scoring system consists of four variables that are used to assess the function of the shoulder. The right and left shoulders are assessed separately. The subjective variables are pain and activities of daily living (ADL) (sleep, work, recreation / sport) which give a total of 35 points. The objective variables are range of motion and strength which give a total of 65 points. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function. | at Baseline | 
| Long head of Biceps Score (LHB-Score) | The LHB score (maximum 100 points) described by Scheibel et al. evaluates the qualities ''biceps pain and muscle cramps'' (maximum 50 points), ''cosmesis (maximum 30 points) and ''flexion strength at the elbow'' (maximum 20 points) | at Baseline | 
| muscle activation determined from electromyographic (EMG) data | The level of muscle activation of the biceps during forearm supination will be expressed as percentage of the peak muscle activation during elbow flexion and compared between the limbs of each patient. The mean frequency of the muscle activation will be calculated using a Fast Fourier Transform in 1s windows. Fatigue will be determined as the change in the mean frequency from the beginning of the endurance task to the end of the endurance task | at Baseline | 
| supination muscle strength | Isometric endurance of forearm supination will be measured in neutral forearm. Participants will be asked to maximally supinate their forearm for as long as possible. Endurance will be quantified as the elapsed time until the patient stops the measurement due to fatigue. | at Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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partial rotator cuff tear, complete rotator cuff tear, proximal biceps tenotomy, proximal biceps tenodesis, arthroscopic rotator cuff tear repair, biceps strength in supination and flexion, Supination Strength Index SSI, lesion of the long head of the biceps tendon (LHBT)