Shoulder Osteoarthritis
Conditions
Brief summary
The aim of this observationnal post-marketing study is to provide additional information on the safety and effectiveness of Simpliciti™ system at 24 months post-shoulder arthroplasty , in usual surgical practice.
Interventions
None listed
Sponsors
Stryker Trauma and Extremities
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A subject must meet all of the following inclusion criteria in order to enter the study: * Adult subject 18 years or older, * 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
* A subject will not be eligible to participate in the study if any of the following conditions is present: * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with device related adverse events as a measure of safety | 24 months | All adverse events will be summarized by the number and percentage of patients with each type of event. The following will be summarized separately: procedure related adverse events, device related adverse events, anticipated adverse events. Additionally, the incidence of serious device associated adverse events will be summarized. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Range of Motions (ROM) as a measure of effectiveness | 24 months | Changes in ROM variables from the pre-implant visit to each follow-up visit will be calculated and sumarized until 24-month visit. |
| Change in the Constant Score as a measure of effectiveness | 24 months | Changes in the Constant Score from the pre-implant visit to each follow-up visits will be calculated and summarized until 24-month visit. |
| Change in the DASH Score as a measure of improvement in the patients' Quality of Life | 24 months | Changes in the DASH Score from the pre-implant visit to each follow-up visits will be calculated and summarised until 24-month visit. |
| Change in humeral cortical thickness as an evaluation of Stress Shielding | 24 months | Changes in humeral cortical thickness from the pre-implant to 24-month visit will be mesured according to the modified method of Tingart & Al. |
Countries
Germany
Outcome results
None listed