EMG and Delta Function in Standard RTSA vs Lateralization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lateralization of glenoid component, Standard implantation technique.
- Who it may be relevant to
- Registry conditions: Cuff Tear Arthropathy, Omarthrosis, Rotator Cuff Tear Arthropathy. Basic parameters: 60 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Postoperative Deltoid EMG Activity and Function in Patients After Reverse Total Shoulder Arthroplasty: A Comparison of Standard Implantation Technique and Lateralization
Overview
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.
Detailed description
Introduction Reverse total shoulder arthroplasty (RTSA) is a well-established method to treat patients with irreparable rotator cuff tears and glenohumeral osteoarthritis. The biomechanical principle is a medialization and distalization of the center of rotation (COR) to provide a compensatory role for the insufficient rotator cuff. Deficiencies in internal and external shoulder rotation constitute frequently seen 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 implants demonstrated increased external rotation force through an alteration of the deltoid's lever arm.
Material and Methods This study will be conducted as a monocentric randomized, prospective trial. Approximately 130 patients, scheduled for reversed total shoulder arthroplasty (RSA), will be enrolled. The patients will be divided into two groups depending on receiving RSA or a lateralized implant via randomization. Preoperatively and at 4 follow-up visits, a surface EMG (sEMG) of the deltoid muscle will be conducted and clinical scores (Constant-Murley Score and Quick DASH questionnaire) will be assessed. As patient related outcome measures, p-ASES-S and SVV will be evaluated. Pre- and postoperative x-rays and CT scans will be conducted for preoperative planning and measurement of achieved lateralization. Clinical and radiological complications will be routinely documented. Group comparisons and correlations will be performed to compare both groups pre- and postoperatively. The study's duration is scheduled for 2 years.
Aim of the Study The aim of the study is to evaluate a possible difference in function and EMG activity between the two patient groups. Especially a different increase in external rotation range of motion and strength shall be investigated. Furthermore a possible connection between preoperative deltoid muscle activity and postoperative outcome shall be pointed out. Lastly, the impact of lateralization on functional outcome, shall be evaluated compared to the standard implantation technique.
Interventions
- Device Lateralization of glenoid component
Lateralization of glenoid component in reverse total shoulder arthroplasty via metal augment on the glenoid side with a thickness of at least 4mm - Device Standard implantation technique
Implantation of a standard glenoid component without any lateralization via metal back on the glenoid site
Primary outcome measures
- Delta Muscle activity (especially posterior Delta part) [Time frame: preoperative]
- Delta Muscle activity (especially posterior Delta part) [Time frame: 6 weeks postoperative]
- Delta Muscle activity (especially posterior Delta part) [Time frame: 3 months postoperative]
- Delta Muscle activity (especially posterior Delta part) [Time frame: 6 months postoperative]
- Delta Muscle activity (especially posterior Delta part) [Time frame: 1 year postoperative]
Secondary outcome measures (11)
- Range of movement (forward flexion, abduction, external rotation, extension) [Time frame: preoperative]
- Range of movement (forward flexion, abduction, external rotation, extension) [Time frame: 6 weeks postoperative]
- Range of movement (forward flexion, abduction, external rotation, extension) [Time frame: 3 months postoperative]
- Range of movement (forward flexion, abduction, external rotation, extension) [Time frame: 6 months postoperative]
- Range of movement (forward flexion, abduction, external rotation, extension) [Time frame: 1 year postoperative]
- Objective and subjective outcome scores / Quality of life scores [Time frame: preoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative, 12 months postoperative]
- Objective and subjective outcome scores / Quality of life scores [Time frame: preoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative, 12 months postoperative]
- Objective and subjective outcome scores / Quality of life scores [Time frame: preoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative, 12 months postoperative]
- Objective and subjective outcome scores / Quality of life scores [Time frame: preoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative, 12 months postoperative]
- Difference in lateralization between preoperative 3D CT-based planning and postoperative CT-based implant position [Time frame: Preoperative and 1 year postoperative]
- Humeral Length (Millimeters) Measured on Standardized Radiographs [Time frame: preoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative, 12 months postoperative]
Eligibility criteria
Inclusion criteria
- male/female, 60-85y
- diagnosis of Cuff tear arthropathy (CTA)
- irreparable rotator cuff tear
- severe osteoarthritis (OA)
- primary RSA
- verified rotator cuff tear in preoperative MRI
- absence of severe cognitive impairment
Exclusion criteria
- previous muscle transfer
- revision surgery
- highly dysplastic glenoid
- axillary nerve palsy
- upper limb radiculopathy
- cervical myelopathy
- degenerative muscular disease,
- previous proximal humeral fracture
- revision arthroplasty
- rheumatoid arthritis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
Austria · 1 center
- Klinik Donaustadt — Vienna
Identifiers
NCT: NCT07464977 · Protocol EMG RTSA 4.0