Evaluating outcomes of stemless reverse shoulder arthroplasty
A Monocentric Clinical Study Evaluating Clinical and Patient-reported Outcomes of Reverse Shoulder Arthroplasty With SMR Stemless
This study is testing how well a new type of shoulder surgery works and if it’s safe for people over a two-year period.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Arthro Medics AG Academic / other |
| Locations | 1 site (Basel, Canton of Basel-City) |
| Trial ID | NCT04529798 on ClinicalTrials.gov |
What this trial studies
This study assesses the clinical, radiographical, and patient-reported outcomes of SMR Stemless Reverse Shoulder Arthroplasty over a follow-up period of at least two years. It includes both retrospective and prospective populations to evaluate the effectiveness and safety of this surgical approach. Participants will be monitored at multiple time points, including baseline, 6 weeks, 6 months, 12 months, and 24 months post-operation. The study aims to identify any complications associated with the procedure.
Who should consider this trial
Good fit: Ideal candidates include adults with rotator cuff tear arthropathy or osteoarthritis of the shoulder who can provide informed consent.
Not a fit: Patients who are pregnant, nursing, or have contraindications for the SMR Stemless device will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and quality of life for patients with shoulder conditions.
How similar studies have performed: Other studies have shown promising results with similar approaches to shoulder arthroplasty, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Basel, Canton of Basel-City
- Arthro Medics AG — Basel, Canton of Basel-City, Switzerland (Recruiting)
Study contacts
- Principal investigator: Claudio Rosso, Prof. Dr. med. — Arthro Medics AG
- Study coordinator: Claudio Rosso, PD Dr. med
- Email: c.rosso@arthro.ch
- Phone: +41 61 301 26 26
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.