osteoarthritis of the shoulder
Conditions
Interventions
None listed
Sponsors
NAMSA
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patient is requiring primary unilateral or bilateral anatomic or reverse arthroplasty based on physical examination and medical history; - Good bone quality evaluated by the Investigator on the basis of a risk factors analysis (included MORES/SCORE questionnaires) and the intraoperative evaluation; - A diagnosis in the target shoulder of one or more of the following: • Primary osteoarthritis; • Secondary osteoarthritis; • Post-traumatic arthritis; • Rheumatoid arthritis; • Avascular necrosis of the humeral head (radiologically less than 20%); • Cuff tear arthropathy. - Patient submitted to previous conservative non-surgical treatments; - Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent; - Patient has participated in the Informed Consent process and has signed the Informed Consent form previously approved by the Ethics Committee.
Exclusion criteria
Exclusion criteria: - Patient requiring revision shoulder arthroplasty; - Osteoporosis with a history of non-traumatic fractures; - Steroid injections within the previous 3 months; - Contralateral shoulder replacement within the previous 3 months; - Extensive avascular necrosis (radiologically more than 20%); - Meta-epiphyseal bony defect (including large cysts); - Post-traumatic tuberosity non-union; - Ongoing septicaemia; - Significant proven or suspicious infection of the target shoulder or any serious infectious disease before the study according to the Investigator; - Significant neurological or musculoskeletal disorders that may compromise functional recovery; - Not recovered axillary nerve palsy; - Non functioning deltoid muscle; - Known or suspicious hypersensitivity to the metal or other components and materials of the implant; - Recurrent medical history of immune-mediated reactions or other systemic immune disorders; - Current treatment or treatment for any malignancy within the previous 2 years before the preoperative visit; - Previous organ transplant; - Women of childbearing potential who are pregnant, nursing, or planning to become pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint consist of the proportion of patients reaching a clinical progression from baseline to 24-month follow-up measured as: • Constant score change of greater than 10; • Adjusted Constant score greater than or equal to 54. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are: • improvement from patient perspective from baseline to 24-month follow-up measured as change of the ASES score, Oxford shoulder score and patient satisfaction; • stability of the humeral component, intended as rate of symptomatic radiolucent lines, loosening and subsidence >=2 mm, from immediate postoperative (baseline) to 24-month; • Failure rate, intended as removal of the humeral component, from immediate postoperative (baseline) to 24-month; • Incidence of device-related AE/SAE (ADE/SADE) from immediate postoperative (baseline) to 24-month. | — |
Countries
Netherlands
Outcome results
None listed