Safety and Effectiveness of the Tornier Simpliciti™ Shoulder System in Shoulder Arthroplasty
NCT ID: NCT02452957
Last Updated: 2017-10-13
Study Results
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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WITHDRAWN
OBSERVATIONAL
2020-01-31
2022-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Device: Simpliciti™ System
The Simpliciti™ nucleus is a humeral prosthesis intended for total and hemi shoulder arthroplasty in patients with a severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis.
The implant is sized to match and replicate the anatomy of the proximal humerus, while maintaining a bone conserving approach. It does not extend beyond the metaphysis, leaving the humeral canal untouched. Fixation is enhanced through a porous coating with a high coefficient of friction; resulting in a solid initial fit and long term fixation.
The Simpliciti™ nucleus is designed to receive a humeral head. The Simpliciti™ system is authorized to bear the CE mark and will be investigated within this clinical study in accordance with its intended use.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Clinical indication for total shoulder or hemi replacement due to primary diagnosis of osteoarthritis,
* Scapula and proximal humerus must have reached skeletal maturity,
* Willing and able to comply with the protocol,
* Willing and able to personally sign the informed consent form,
* Subject is legally competent, understands the nature, significance and implications of the clinical investigation, and is able to form a rational intention in the light of these facts.
Exclusion Criteria
* lack of sufficient sound bone to seat and support the implant, including that resulting from skeletal immaturity, osteoporosis or erosive arthritis,
* Severe Walch grade B2 glenoid defined as \>60% posterior head displacement and \>20% posterior glenoid bone loss,
* metal allergies or sensitivity,
* infection at or near the site of implantation,
* distant or systemic infection.
18 Years
ALL
No
Sponsors
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Stryker Trauma and Extremities
INDUSTRY
Responsible Party
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Principal Investigators
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Steve A. Erickson
Role: STUDY_DIRECTOR
Stryker Trauma and Extremities
Ulrich Brunner, MD, Prof.
Role: PRINCIPAL_INVESTIGATOR
Krankenhaus Agatharied
Locations
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Krankenhaus Agatharied
Hausham, , Germany
Countries
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Other Identifiers
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1206-T-SIMPLICITI-RM
Identifier Type: -
Identifier Source: org_study_id