Status:
COMPLETED
Patient Benefit From the New Modular Shoulder Prosthesis PROMOS
Lead Sponsor:
Smith & Nephew Orthopaedics AG
Conditions:
Primary or Secondary Omarthrosis of the Shoulder Joint
Eligibility:
All Genders
18+ years
Brief Summary
Overall study design: This study is a prospective, non-randomized, multicenter postmarket clinical follow-up study with two study arms using the two shoulder prosthesis PROMOS™ STANDARD (group A) and...
Detailed Description
Primary objective of the study: The primary objective is to quantify patient benefit after primary total shoulder arthroplasty with the modular PROMOS™ shoulder system in a multicenter cohort study (...
Eligibility Criteria
Inclusion
- Eligibility:
- Ages eligible for study: minimal age of 18 years
- Genders eligible for study: both
- Accepts healthy volunteers: no
- Primary or secondary omarthrosis as an indication for primary total shoulder arthroplasty
- Massive rotator cuff rupture
- Willing an able to give written informed consent to participate in the study including follow-ups
Exclusion
- Previous ipsilateral shoulder arthroplasty (group A and B)
- Late stage rotator cuff disease (only group A)
- Acute shoulder trauma (group A and B)
- General medical contraindication to surgery (group A and B)
- Legal incompetence (group A and B)
- Tumour / malignoma (group A and B)
- Recent history of substance abuse (group A and B)
- Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder) (group A and B)
- Known hypersensitivity to the materials used (group A and B)
- Bacterial infection at the time point of operation (group A and B)
Key Trial Info
Start Date :
June 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT00925496
Start Date
June 1 2009
End Date
December 1 2019
Last Update
April 6 2020
Active Locations (2)
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1
Orthopaedische Praxis / Praxisklinik
Münster, Germany
2
Schulthess Klinik
Zurich, Switzerland, 8008