Clinical Study Evaluating Outcomes of Reverse Shoulder Arthroplasty With SMR Stemless

NCT ID: NCT04529798

Last Updated: 2024-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-22

Study Completion Date

2025-08-30

Brief Summary

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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

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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

Conditions

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Rotator Cuff Tear Arthropathy Osteo Arthritis Shoulders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arthro Medics AG

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. med Claudio Rosso

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudio Rosso, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Arthro Medics AG

Locations

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Arthro Medics AG

Basel, Canton of Basel-City, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Claudio Rosso, PD Dr. med

Role: CONTACT

+41 61 301 26 26

Facility Contacts

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Claudio Rosso, PD Dr. med.

Role: primary

+41 61 301 26 26

Other Identifiers

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S-35

Identifier Type: -

Identifier Source: org_study_id

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