Clinical Trials Directory

Trials / Completed

CompletedNCT04393662

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
16 (actual)
Sponsor
University Hospital, Basel, Switzerland · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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. 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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTMeasurement 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_TESTRange 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_TESTElectromyography (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)

Timeline

Start date
2019-11-25
Primary completion
2020-03-05
Completion
2020-03-05
First posted
2020-05-19
Last updated
2022-12-12

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT04393662. Inclusion in this directory is not an endorsement.