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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RECRUITING
NA
100 participants
INTERVENTIONAL
2022-01-05
2027-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mirror group
Mirror Medacta Shoulder System
Mirror Medacta Shoulder System
Anatomic total shoulder arthroplasty system
Historical Control group
Total shoulder arthroplasty system
Medacta Shoulder System
Anatomic total shoulder arthroplasty system - standard configuration
Interventions
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Mirror Medacta Shoulder System
Anatomic total shoulder arthroplasty system
Medacta Shoulder System
Anatomic total shoulder arthroplasty system - standard configuration
Eligibility Criteria
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Inclusion Criteria
* Clinical indication for anatomic primary total shoulder replacement due to osteoarthritis and/or posttraumatic arthritis
* Willingness and ability to comply with study protocol
Exclusion Criteria
* Prior rotator cuff surgery
* Cuff tear arthropathy/insufficient rotator cuff
* Insufficient bone quality which may affect the stability of the implant
* Neuromuscular compromise of shoulder or other disabilities affecting the maximum functional outcomes
* Weight bearing shoulder due to wheel chair, crutches, rollator at the time of operation
* Active metastatic or neoplastic disease at the shoulder joint
* Chemotherapy treatment/radiotherapy within 6 mo before surgery
* \>5 mg/day of corticosteroids, excluding inhalers, within 3 years before surgery
* Pregnancy or plan to become pregnant during study period
* Inability to understand study or a history of noncompliance with medical advice
* Alcohol or drug abuse
* Current enrollment in any clinical research study that might interfere with this study
* Metal allergies or sensitivity.
* Previous or current infection at or near the site of implantation.
* Current distant or systemic infection
* Patient, whose infomed consent form should be taken in an emergency situation
* ONLY for women of childbearing age: a positive pregnancy test (urine / blood)
18 Years
ALL
No
Sponsors
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Medacta International SA
INDUSTRY
Responsible Party
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Principal Investigators
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Matthias A Zumstein, Prof Dr. med
Role: PRINCIPAL_INVESTIGATOR
Lindenhofgruppe AG (Bern)
Locations
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Lindenhofgruppe AG - Orthopädie Sonnenhof
Bern, , Switzerland
Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital St.Gallen
Sankt Gallen, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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P06.003.01
Identifier Type: -
Identifier Source: org_study_id
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