Postoperative Biceps Strength and Electromyographic Activity After Proximal Biceps Tenotomy Versus Tenodesis in Patients With Arthroscopic Rotator Cuff Tear Repair
NCT ID: NCT04393662
Last Updated: 2022-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
16 participants
OBSERVATIONAL
2019-11-25
2020-03-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tenodesis group
Tenodesis as surgical treatment option for a lesion of the long head of the biceps tendon (LHBT)
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.
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
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)
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.
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
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)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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
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)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 1-4 years postoperative
* Written informed consent
Exclusion Criteria
* Previous biceps injury and or operation
* Contralateral biceps injury
* Neurological disorders potentially affecting upper extremity muscle strength.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Basel, Switzerland
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andreas Mueller, PD Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Orthopädie/Traumatologie University Hospital Basel
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Orthopädie/Traumatologie University Hospital Basel
Basel, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-02004; ch20Taha
Identifier Type: -
Identifier Source: org_study_id