Status:
COMPLETED
Multicenter Clinical Observation PROMOS®
Lead Sponsor:
Smith & Nephew Orthopaedics AG
Conditions:
Primary and Secondary Omarthrosis
Eligibility:
All Genders
18+ years
Brief Summary
Overall study design: This study is a prospective, multicenter, postmarket clinical observation to validate the PROMOS™ Standard Shoulder System as state-of-the-art implant system for total shoulder ...
Detailed Description
Primary objective: Radiological and clinical loosening rates of the glenoid and humeral components must be comparable or below the rates of other well documented state-of-the-art shoulder systems wit...
Eligibility Criteria
Inclusion
- patient has no general medical contraindication to surgery
- informed consent to participate in the observation signed by the patient
- routine radiographic assessment is possible
- patient is likely to comply with study follow-up requirements
- primary total- or hemi-shoulder-arthroplasty to the affected side, unilateral or bilateral
Exclusion
- acute shoulder trauma
- tumor / malignoma
- avascular necrosis
- late stage rotator cuff disease
- Charcot joint disease or other severe neurosensory deficits
- high comorbidity
- previously failed shoulder arthroplasty
- fracture sequelae of proximal humerus
- hypersensitivity to the implant materials used
- addictive disorders such as alcohol or drug abuse
- severe spinal disorders
- bacterial infections
Key Trial Info
Start Date :
November 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT02280499
Start Date
November 1 2003
End Date
March 1 2015
Last Update
March 21 2016
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