Biceps Tendon LesionTenTedNCT04393662
Postoperative Biceps Strength and Electromyographic Activity After Proximal Biceps Tenotomy Versus Tenodesis in Patients With Arthroscopic Rotator Cuff Tear Repair
An observational study of Biceps Tendon Lesion, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biceps Tendon Lesion
- What is being tested?
- Measurement of Muscle strength using a dynamometer, Range of motion clinical measurement (shoulder and elbow) and Electromyography (EMG)
- How many people
- 16 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Nov 2019to 5 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patient after an arthroscopic rotator cuff repair who underwent a biceps tenotomy or tenodesis
- 1-4 years postoperative
- Written informed consent
Who cannot join
- Inability to provide informed consent
- Previous biceps injury and or operation
- Contralateral biceps injury
- Neurological disorders potentially affecting upper extremity muscle strength.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Orthopädie/Traumatologie University Hospital Basel
Basel, 4031
About this study
Official title: 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.
Read the 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.
- Conditions
- Biceps Tendon Lesion
- Being tested
- Measurement of Muscle strength using a dynamometer, Range of motion clinical measurement (shoulder and elbow), Electromyography (EMG)
- 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)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of Muscle strength using a dynamometerDiagnostic test
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.
Range of motion clinical measurement (shoulder and elbow)Diagnostic test
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
Electromyography (EMG)Diagnostic test
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)
| Study group | Role | What they receive |
|---|---|---|
| Tenodesis group | Tenodesis as surgical treatment option for a lesion of the long head of the biceps tendon (LHBT) Receives: Diagnostic Test: Measurement of Muscle strength using a dynamometer; Diagnostic Test: Range of motion clinical measurement (shoulder and elbow); Diagnostic Test: Electromyography (EMG) | |
| Tenotomy group | Tenotomy as surgical treatment option for a lesion of the long head of the biceps tendon (LHBT) Receives: Diagnostic Test: Measurement of Muscle strength using a dynamometer; Diagnostic Test: Range of motion clinical measurement (shoulder and elbow); Diagnostic Test: Electromyography (EMG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at Baseline
Secondary outcomes (6)
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
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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.
Measured: at Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start25 Nov 2019
- Primary completion5 Mar 2020
- Study completion5 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biceps Tendon LesionStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Mueller, PD Dr. med., Principal investigator, Orthopädie/Traumatologie University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393662
- Sponsor's protocol ID
- 2019-02004; ch20Taha
- Other IDs
- 2019
- Acronym
- TenTed
- Status last verified
- Dec 2022
- First submitted
- 14 May 2020
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TenTed-Postoperative Biceps Strength and Electromyographic Activity After Proximal Biceps Tenotomy Versus Tenodesis in Patients With Arthroscopic Rotator Cuff Tear Repair
- ClinicalTrials.gov ID
- NCT04393662
- Acronym / sponsor ID
- TenTed / 2019-02004; ch20Taha
- Conditions
- Biceps Tendon Lesion
- 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)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tenodesis group | – | Diagnostic Test: Measurement of Muscle strength using a dynamometer, Diagnostic Test: Range of motion clinical measurement (shoulder and elbow), Diagnostic Test: Electromyography (EMG)Tenodesis as surgical treatment option for a lesion of the long head of the biceps tendon (LHBT) |
| Tenotomy group | – | Diagnostic Test: Measurement of Muscle strength using a dynamometer, Diagnostic Test: Range of motion clinical measurement (shoulder and elbow), Diagnostic Test: Electromyography (EMG)Tenotomy as surgical treatment option for a lesion of the long head of the biceps tendon (LHBT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patient after an arthroscopic rotator cuff repair who underwent a biceps tenotomy or tenodesis
- 1-4 years postoperative
- Written informed consent
Key exclusion criteria (4 listed)
- Inability to provide informed consent
- Previous biceps injury and or operation
- Contralateral biceps injury
- Neurological disorders potentially affecting upper extremity muscle strength.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of Muscle strength using a dynamometerMuscle 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 | Tenodesis group, Tenotomy group |
| 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 | Tenodesis group, Tenotomy group |
| 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) | Diagnostic test | Tenodesis group, Tenotomy group |
Primary outcome
Supination Strength Index SSI
Time frame: at Baseline
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.
6 secondary outcomes
patient's pain visual analog scale Score (VAS)
Time frame: at Baseline
American Shoulder and Elbow Surgeons (ASES) Score
Time frame: at Baseline
Constant Score
Time frame: at Baseline
Long head of Biceps Score (LHB-Score)
Time frame: at Baseline
muscle activation determined from electromyographic (EMG) data
Time frame: at Baseline
supination muscle strength
Time frame: at Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
Related trials for Biceps Tendon Lesion
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Arthroscopic Rotator Cuff Repair With Long Head of Biceps Transposition and Acellular Dermal Matrix Augmentation for Large to Massive Incompletely Repairable Rotator Cuff Tears
Rotator Cuff Tears, Rotator Cuff Injuries
Recruiting
Biceps Tenodesis With 360 Suture Anchor Versus Self Locking Tenodesis In the Absence of Rotator Cuff Tears
SLAP Lesion
Not yet recruiting
Arthroscopic Rotator Cuff Repair Trial
Rotator Cuff Tears
Not yet recruitingObservational study
Reliability and Accuracy of a New Clinical Test for Biceps Lesions
Lesion of Long Head of Biceps, SLAP Lesion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Mueller, PD Dr. med. principal investigator
Orthopädie/Traumatologie University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biceps Tendon Lesion, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Supination Strength Index SSI (time frame: at Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2022.