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

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

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.

Study Overview

• Status: Completed
• Conditions: Biceps Tendon Lesion
• Intervention / Treatment: Diagnostic test: Measurement of Muscle strength using a dynamometer; Diagnostic test: Range of motion clinical measurement (shoulder and elbow); Diagnostic test: Electromyography (EMG)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Orthopädie/Traumatologie University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients will be asked to participate in clinical and functional analysis after an arthroscopic rotator cuff repair who underwent a biceps tenotomy or tenodesis (1 to 4 years after surgery) at the University Hospital Basel between Jan 2015 and Oct 2018.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tenodesis group; 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; 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.; Diagnostic test: Range of motion clinical measurement (shoulder and elbow); 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; Diagnostic test: Electromyography (EMG); 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)
Tenotomy group; 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; 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.; Diagnostic test: Range of motion clinical measurement (shoulder and elbow); 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; Diagnostic test: Electromyography (EMG); 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Andreas Mueller, PD Dr. med., Orthopädie/Traumatologie University Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2019
• Primary Completion (Actual): March 5, 2020
• Study Completion (Actual): March 5, 2020

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Estimate): December 12, 2022
• Last Update Submitted That Met QC Criteria: December 9, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: 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)
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 2019-02004; ch20Taha

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No