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NCT04529798 Clinical Trial

Clinical Study Evaluating Outcomes of Reverse Shoulder Arthroplasty With SMR Stemless

Rotator Cuff Tear Arthropathy Clinical Trial

— SSPR  

Official title:
A Monocentric Clinical Study Evaluating Clinical and Patient-reported Outcomes of Reverse Shoulder Arthroplasty With SMR Stemless

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04529798
Other study ID # S-35
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 22, 2016
Est. completion date August 30, 2024

Study information
Verified date July 2022
Source Arthro Medics AG
Contact Claudio Rosso, PD Dr. med
Phone +41 61 301 26 26
Email c.rosso@arthro.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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): - Baseline - 6 weeks postop - 6 months postop - 12 months postop - 24 months postop

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date August 30, 2024
Est. primary completion date August 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - rotator-cuff arthropathy, osteoarthritis - approving written informed consent Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Switzerland Arthro Medics AG Basel Basel-Stadt

Sponsors (1)
Lead Sponsor Collaborator
Arthro Medics AG

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Subjective Shoulder Value score Evaluation of the change of the Subjective Shoulder Value score from pre-operative to the last follow-up visit. 5 years
Secondary ASES Shoulder Score Evaluation of the change of the ASES shoulder score from pre-operative to the last follow-up visit. 5 years
Secondary Quick-Dash score Evaluation of the change of the Quick-Dash score from pre-operative to the last follow-up visit. 5 years
Secondary VAS pain Evaluation of the change of the VAS pain score from pre-operative to the last follow-up visit. 5 years
Secondary UCLA shoulder score Evaluation of the change of the UCLA shoulder score from pre-operative to the last follow-up visit. 5 years
Secondary Loosening, implant stability, radiolucent lines Radiographic evaluation of the implant stability as rate and progression of symptomatic radiolucent lines and loosening. 1 year
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