An observational study in Rotator Cuff Tear Arthropathy and Osteo Arthritis Shoulders, sponsored by Arthro Medics AG. Status unknown at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-31.
Sponsored by Arthro Medics AG · Observational
The objectives of this study are the assessment of the clinical, radiographical and patient-reported outcomes of SMR Stemless Reverse Shoulder Arthroplasty (LimaCorporate S.p.A.) used as standard of care over a period of at least 2 years of follow-up and the evaluation of the incidence of any complication.
The focus of this study is the evaluation on clinical, patient-reported and radiographical outcomes of SMR Stemless Reverse Shoulder Arthroplasty. There is a retrospective and prospective study population.
The follow up time-points are (as of standard of care and not different for this study):
57 studies on the registry are indexed under Rotator Cuff Tear Arthropathy; 15 are open to participants now.
This study's planned enrollment of 60 is below the median of 150 across 21 observational studies indexed under Rotator Cuff Tear Arthropathy.
Browse Rotator Cuff Tear Arthropathy studies →This is the only study on the registry with Arthro Medics AG as lead sponsor.
Counted across the registry records on this site, refreshed daily.
There is a retrospective and prospective study population. All participants are older than 18 years old and approved the written informed consent. Additionally they are suffering from rotator-cuff arthropathy and/or osteoarthritis.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjective Shoulder Value score
Evaluation of the change of the Subjective Shoulder Value score from pre-operative to the last follow-up visit.
Time frame: 5 years
ASES Shoulder Score
Evaluation of the change of the ASES shoulder score from pre-operative to the last follow-up visit.
Time frame: 5 years
Quick-Dash score
Evaluation of the change of the Quick-Dash score from pre-operative to the last follow-up visit.
Time frame: 5 years
VAS pain
Evaluation of the change of the VAS pain score from pre-operative to the last follow-up visit.
Time frame: 5 years
UCLA shoulder score
Evaluation of the change of the UCLA shoulder score from pre-operative to the last follow-up visit.
Time frame: 5 years
Loosening, implant stability, radiolucent lines
Radiographic evaluation of the implant stability as rate and progression of symptomatic radiolucent lines and loosening.
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2016 (actual). Primary completion is estimated for Aug 2024, 93 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Rotator Cuff Tear Arthropathy →