Clinical Study Evaluating Outcomes of Reverse Shoulder Arthroplasty With SMR Stemless
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorArthro Medics AG
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
rotator-cuff arthropathy, osteoarthritis
approving written informed consent
Disqualifiers
Female patients who are pregnant, nursing, or planning a pregnancy.
All adult patients with any of the SMR Stemless contraindication for use for the reverse configuration as reported in the current local Instruction for use.
not consenting in participating in this study
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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 yearsSecondary outcomes
1
ASES Shoulder Score
Evaluation of the change of the ASES shoulder score from pre-operative to the last follow-up visit.
Time frame
5 years2
Quick-Dash score
Evaluation of the change of the Quick-Dash score from pre-operative to the last follow-up visit.
Time frame
5 years3
VAS pain
Evaluation of the change of the VAS pain score from pre-operative to the last follow-up visit.
Time frame
5 years4
UCLA shoulder score
Evaluation of the change of the UCLA shoulder score from pre-operative to the last follow-up visit.
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov