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Post-Market Clinical Follow-up Study to the AGILON® Shoulder System

Post-Market Clinical Follow-up Study to the AGILON® Shoulder System - prospective multi-center follow-up study -

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0007616
Enrollment
100
Registered
2022-08-05
Start date
2019-01-28
Completion date
Unknown
Last updated
2022-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Implantcast Asia
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
SSV score, KSS, EQ-5D—

Secondary

MeasureTime frame
Radiologic evaluation (Scapular notching, osteolysis, low signal intensity or loosening)—

Countries

Korea, Republic of

Contacts

Public ContactYoo-Sun Won

Seoul National University Bundang Hospital

wys0199@gmail.com+82-31-787-1187

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026