N/A
N=87
Multicenter Clinical Observation PROMOS®
Primary and Secondary Omarthrosis
Bottom Line
View on ClinicalTrials.gov: NCT02280499 ↗Enrolled (actual)
87
Serious AEs
35.6%
Results posted
Mar 2016
Primary outcome: Primary: Radiological and Clinical Loosening Rates of the Glenoid and Humeral Components — 96.29 Percentage survivorship
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- standard PROMOS prosthesis (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Smith & Nephew Orthopaedics AG
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radiological and Clinical Loosening Rates of the Glenoid and Humeral Components |
96.29 | — |
| SECONDARY Constant Murley Score |
72.80 | — |
| SECONDARY ASES Shoulder Score Index |
76.88 | — |
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 arthroplasty in terms of radiographic and clinical performance as well as long-term survivorship over 10 years.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02280499). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.