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EMG and Delta Function in Standard RTSA vs Lateralization

ConditionsCuff Tear ArthropathyOmarthrosisRotator Cuff Tear Arthropathy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-85
SponsorVienna Hospital Association

About this trial

Reverse total shoulder arthroplasty (RTSA) is a well-established method to treat patients with irreparable rotator cuff tears and glenohumeral osteoarthritis. The biomechanical principle implies a medialization and distalization of the center of rotation (COR). Deficiencies in internal and external rotation constitute frequently encountered functional problems. Some studies showed reduced activation of the posterior deltoid in EMG measurements, which may explain the inability to compensate these movements. Lateralized prosthetic designs demonstrated increased external rotation through an alteration of the deltoid's lever arm.

The aim of the study is to investigate the impact of lateralization on functional outcome and deltoid EMG activity in comparison to a standard implantation technique.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

male/female, 60-85y

diagnosis of Cuff tear arthropathy (CTA)

irreparable rotator cuff tear

severe osteoarthritis (OA)

Disqualifiers

previous muscle transfer

revision surgery

highly dysplastic glenoid

axillary nerve palsy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lateralization of glenoid component

    Device

    Lateralization of glenoid component in reverse total shoulder arthroplasty via metal augment on the glenoid side with a thickness of at least 4mm

  • Standard implantation technique

    Device

    Implantation of a standard glenoid component without any lateralization via metal back on the glenoid site

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Standard Implantation GroupActive comparator 1 intervention
Group B: Lateralized Implantation GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Delta Muscle activity (especially posterior Delta part)

The ratio between peak torque and EMG root mean square is measured

Time frame
preoperative
2

Delta Muscle activity (especially posterior Delta part)

The ratio between peak torque and EMG root mean square is measured

Time frame
6 weeks postoperative
3

Delta Muscle activity (especially posterior Delta part)

The ratio between peak torque and EMG root mean square is measured

Time frame
3 months postoperative
4

Delta Muscle activity (especially posterior Delta part)

The ratio between peak torque and EMG root mean square is measured

Time frame
6 months postoperative

Secondary outcomes

1

Range of movement (forward flexion, abduction, external rotation, extension)

ROM (range of movement) measured with a goniometer according to neutral zero method

Time frame
preoperative
2

Range of movement (forward flexion, abduction, external rotation, extension)

ROM (range of movement) measured with a goniometer according to neutral zero method

Time frame
6 weeks postoperative
3

Range of movement (forward flexion, abduction, external rotation, extension)

ROM (range of movement) measured with a goniometer according to neutral zero method

Time frame
3 months postoperative
4

Range of movement (forward flexion, abduction, external rotation, extension)

ROM (range of movement) measured with a goniometer according to neutral zero method

Time frame
6 months postoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vienna Hospital Association

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: