A Monocentric Clinical Study Evaluating Clinical and Patient-reported Outcomes of Reverse Shoulder Arthroplasty With SMR Stemless
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rotator Cuff Tear Arthropathy
- Sponsor
- Arthro Medics AG
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Subjective Shoulder Value score
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed 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
Investigators
Prof. Dr. med Claudio Rosso
Principal Investigator
Arthro Medics AG
Eligibility Criteria
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
Outcomes
Primary Outcomes
Subjective Shoulder Value score
Time Frame: 5 years
Evaluation of the change of the Subjective Shoulder Value score from pre-operative to the last follow-up visit.
Secondary Outcomes
- ASES Shoulder Score(5 years)
- Loosening, implant stability, radiolucent lines(1 year)
- Quick-Dash score(5 years)
- UCLA shoulder score(5 years)
- VAS pain(5 years)