Rotator Cuff Tear Arthropathy, Rotator Cuff Tears
Conditions
Brief summary
Determine the optimal degree of retroversion (0-30º) to obtain the best rotational mobility, both internal and external, of the shoulder after implanting a reversed sghoulder arthroplasty (Comprehensive system), and analyze the functional and radiologic results based on humeral retroversion.
Detailed description
Methodology: Open randomized controlled clinical trial. It will be carried out with patients operated with reverse shoulder arthroplasty (at 0º and 30º of humeral retroversion) included consecutively in Terrassa Hospital from January 2019 to June 2021. The estimated sample will be 30 patients per group with diagnosis of massive rotator cuff rupture, rotator cuff arthropaty and primary osteoarthritis with cuff injury, with Walch's type B2 glena or in patients older than 80 years. A global study will be carried out preoperatively and postoperatively with radiographs, computerized tomography, magnetic resonance, and a biomechanical study.
Interventions
PROCEDUREhumeral retroversion
REVERSED SHOULDER ARTHROPLASTY IN TWO DIFFERENT GROUPS. Group 0 humeral retroversion, Group 30º humeral retroversion
Sponsors
Consorci Sanitari de Terrassa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Open randomized controlled clinical trial.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* men and women over 60 with the diagnosis rotator cuff massive break (Hamada 2 or more), arthrosis secondary to ruptures of the rotator cuff and primary osteoarthritis with lesion of the cuff, with full Walch B2 type or in patients older than 80 years. Inclusion criteria * Good functionality of the deltoid muscle. * Presence of minor round (Hornblower test - no muscle atrophy in nuclear magnetic resonance) * Accept informed consent
Exclusion criteria
* \- Review of hemiarthroplasty or anatomical proesis of the affected shoulder. * Fracture of shoulder in the upper extremity to intervene. * Central neurological diseases * Advanced cognitive impairment * Brachial plexus injuries * Local or systemic infection. * Oncological disease * Treatment with immunosuppressants.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| INTERNAL ROTATION | 2 YEARS | AT THE SIDE (HAND TO the BACK from CONSTANT TEST) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FORWARD ELEVATION | 2 YEARS | degrees |
| Simple shoulder test | 2 years | 0-100 |
| Constant test | 2 years | 0-100 |
| ASES test | 2 years | 0-100 |
| EXTERNAL ROTATION | 2 YEARS | degrees |
| glenoid retroversion angle | 2 years | degrees |
| abduction | 2 years | degrees |
| center of rotation | 2 years | milimiters |
| lateralizaiton offset | 2 years | milimiters |
| Glenoid inclination angle | 2 years | degrees |
Countries
Spain
Outcome results
None listed