Clinical Study Evaluating Outcomes of Reverse Shoulder Arthroplasty With SMR Stemless

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04529798

Acronym

SSPR

Enrollment

Registered

2020-08-28

Start date

2016-11-22

Completion date

2025-08-30

Last updated

2024-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteo Arthritis Shoulders, Rotator Cuff Tear Arthropathy

Keywords

stemless reverse shoulder arthroplasty

Brief 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.

Detailed 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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Subjective Shoulder Value score	5 years	Evaluation of the change of the Subjective Shoulder Value score from pre-operative to the last follow-up visit.

Secondary

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

Countries

Switzerland

Contacts

Primary ContactClaudio Rosso, PD Dr. med

c.rosso@arthro.ch+41 61 301 26 26

Outcome results