Clinical Study Evaluating Outcomes of Reverse Shoulder Arthroplasty With SMR Stemless

Recruiting

• Conditions: Osteo Arthritis Shoulders; Rotator Cuff Tear Arthropathy

• Registration Number: NCT04529798
• Lead Sponsor: Arthro Medics AG

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

Study Timeline

• Study Start: 2016-11-22
• Study First Submitted: 2020-08-25
• Study First Submitted QC: 2020-08-25
• Study First Posted: 2020-08-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31
• Primary Completion: 2024-08-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Quick-Dash score	5 years	Evaluation of the change of the Quick-Dash score from pre-operative to the last follow-up visit.
ASES Shoulder Score	5 years	Evaluation of the change of the ASES 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.
UCLA shoulder score	5 years	Evaluation of the change of the UCLA shoulder 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.

Trial Locations

Locations (1)

Arthro Medics AG; 🇨🇭 Basel, Basel-Stadt, Switzerland