Clinical Study Evaluating Outcomes of Reverse Shoulder Arthroplasty With SMR Stemless (SSPR)

July 20, 2022 updated by: Prof. Dr. med Claudio Rosso, Arthro Medics AG

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Claudio Rosso, PD Dr. med
  • Phone Number: +41 61 301 26 26
  • Email: c.rosso@arthro.ch

Study Contact Backup

Study Locations

  • Switzerland
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4054
        • Recruiting
        • ARTHRO Medics AG
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study 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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arthro Medics AG

Investigators

  • Principal Investigator: Claudio Rosso, PD Dr. med., ARTHRO Medics AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2016

Primary Completion (Anticipated)

August 30, 2023

Study Completion (Anticipated)

August 30, 2024

Study Registration Dates

First Submitted

August 25, 2020

First Submitted That Met QC Criteria

August 25, 2020

First Posted (Actual)

August 28, 2020

Study Record Updates

Last Update Posted (Actual)

July 25, 2022

Last Update Submitted That Met QC Criteria

July 20, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-35

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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