Clinical Study Evaluating Outcomes of Reverse Shoulder Arthroplasty With SMR Stemless (SSPR)

Arthro Medics

Status: Enrolling

Conditions: Osteo Arthritis Shoulders; Rotator Cuff Tear Arthropathy

Study type: Observational

Funder types: Other

Identifiers

NCT04529798

S-35

Details and patient eligibility

About

The objectives of this study are the assessment of the clinical, radiographical and patient-reported outcomes of SMR Stemless Reverse Shoulder Arthroplasty (LimaCorporate S.p.A.) used as standard of care over a period of at least 2 years of follow-up and the evaluation of the incidence of any complication.

Full description

The focus of this study is the evaluation on clinical, patient-reported and radiographical outcomes of SMR Stemless Reverse Shoulder Arthroplasty. There is a retrospective and prospective study population.

The follow up time-points are (as of standard of care and not different for this study):

• Baseline
• 6 weeks postop
• 6 months postop
• 12 months postop
• 24 months postop

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• rotator-cuff arthropathy, osteoarthritis
• approving written informed consent

Exclusion criteria

• Female patients who are pregnant, nursing, or planning a pregnancy.
• All adult patients with any of the SMR Stemless contraindication for use for the reverse configuration as reported in the current local Instruction for use.
• not consenting in participating in this study