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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Osteo Arthritis Shoulders
• Osteoarthritis
• Rotator Cuff Injuries
• Rotator Cuff Tear Arthropathy

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