Post-Market Clinical Follow-up Study to the AGILON® Shoulder System
Not Applicable
Recruiting
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0007616
- Lead Sponsor
- Implantcast Asia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Patients aged 60 and over, who is subject to reverse artificial shoulder replacement due to massiver rotator cuff tear, bone defect or rotator cuff tear arthropathy will be included
Exclusion Criteria
1) If reverse shoulder replacement is performed due to an acute fracture or the sequelae of a previous fracture
2) Acute or chronic infection around the shoulder joint
3) Patients with neurological dysfunction, including axillary nerve injury
4) Patients who do not have medical consent, such as language or cognitive impairment
5) an immuno-suppressed patient
6) Psychiatric patients who may have an effect on the outcome and rehabilitation of the selected patients
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SSV score, KSS, EQ-5D
- Secondary Outcome Measures
Name Time Method Radiologic evaluation (Scapular notching, osteolysis, low signal intensity or loosening)