Sidus(TM) Post Market Clinical Follow-up (PMCF) Study (NCT01700543) | Clinical Trial Compass
CompletedNot Applicable
Sidus(TM) Post Market Clinical Follow-up (PMCF) Study
Austria, France, Germany152 participantsStarted 2012-10
Plain-language summary
This post market clinical follow-up study is designed to confirm safety and performance of the Sidus Stem-Free Shoulder when used in hemi or total shoulder arthroplasty.
The safety of the implant will be evaluated by monitoring the frequency and incidence of all kinds of adverse events.
The performance will be determined by analyzing the implant survival, overall pain and functional performances (based on Constant \& Murley score and ASES score), subject quality of life (EuroQol EQ5D) and radiographic parameters (e.g. radiolucencies, osteolysis, component migration) of study subjects who received the Sidus Stem-Free Shoulder.
The Sidus Stem-Free Shoulder is not approved for use in the US.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient is 18 to 80 years of age, inclusive.
* The patient is skeletally mature.
* Patient is suffering from severe shoulder pain and disability requiring unilateral or bilateral HSA or TSA based on physical exam and medical history.
* Patient has failed conservative treatment.
* Patient meets at least one of the following indications: Osteoarthritis, Posttraumatic arthrosis, Rheumatoid arthritis without humeral metaphyseal defects, Focal avascular necrosis of the humeral head, Previous surgeries of the shoulder that do no compromise the fixation.
* Patient is willing and able to cooperate in the required post-operative therapy.
* 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 Ethics Committee approved "Informed Consent".
Exclusion Criteria:
* Patient is unwilling or unable to give consent or to comply with the follow-up program.
* Patients who have any condition which would in the judgement of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, or is an known drug abuser, a known alcoholic or anyone who cannot understand what is required of them.
* Patient is known to be pregnant or breastfeeding.
* Patient meets at least one of the contraindications: Soft or inadequate humeral bone (including osteoporosis and extensive avascular necrosis or rheumat…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study tracked people with conditions like osteoarthritis, rheumatoid arthritis, and avascular necrosis who received the Sidus stem-free shoulder implant — given that it's now completed, has my doctor seen the published results, and what do those findings suggest about how well it works for someone with my specific diagnosis?
2The main thing this study measured was the Constant and Murley Score, which grades shoulder function and pain — what kind of improvement in that score might realistically be expected for someone in my situation, and how does that compare to what I could expect from non-surgical treatment?
3Since this was a post-market follow-up study rather than a traditional randomized controlled trial, what does that mean for how confident my doctor is in the safety and long-term performance data for this implant?
4The Sidus implant is a stem-free design, which is different from traditional shoulder replacements — can my doctor explain whether my bone quality and anatomy make me a good or poor candidate for a stem-free system compared to a conventional stemmed implant?
5This study included people with both non-inflammatory conditions like osteoarthritis and inflammatory conditions like rheumatoid arthritis — does the evidence from this trial apply equally to my specific condition, or are the outcomes meaningfully different depending on the underlying diagnosis?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.