A multicentre, prospective clinical study analysing outcomes of shoulder arthroplasty with SMR STEMLESS
- Conditions
- cuff tear arthropathy1002321310005944osteoarthritis of the shoulder
- Registration Number
- NL-OMON47760
- Lead Sponsor
- AMSA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
- 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.
- 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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint consist of the proportion of patients reaching a clinical<br /><br>progression from<br /><br>baseline to 24-month follow-up measured as:<br /><br>• Constant score change of greater than 10;<br /><br>• Adjusted Constant score greater than or equal to 54.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoints are:<br /><br>• improvement from patient perspective from baseline to 24-month follow-up<br /><br>measured as change of the ASES score, Oxford shoulder score and patient<br /><br>satisfaction;<br /><br>• stability of the humeral component, intended as rate of symptomatic<br /><br>radiolucent lines, loosening and subsidence >=2 mm, from immediate postoperative<br /><br>(baseline) to 24-month;<br /><br>• Failure rate, intended as removal of the humeral component, from immediate<br /><br>postoperative (baseline) to 24-month;<br /><br>• Incidence of device-related AE/SAE (ADE/SADE) from immediate postoperative<br /><br>(baseline) to 24-month.</p><br>