NCT04529798

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 22, 2016

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

7.8 years

First QC Date

August 25, 2020

Last Update Submit

July 30, 2024

Conditions

Rotator Cuff Tear ArthropathyOsteo Arthritis Shoulders

Keywords

stemless reverse shoulder arthroplasty

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • ASES Shoulder Score

    5 years

  • Quick-Dash score

    5 years

  • VAS pain

    5 years

  • UCLA shoulder score

    5 years

  • Loosening, implant stability, radiolucent lines

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • rotator-cuff arthropathy, osteoarthritis
  • approving written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arthro Medics AG

Basel, Canton of Basel-City, 4054, Switzerland

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy

Condition Hierarchy (Ancestors)

ChondrocalcinosisArthritisJoint DiseasesMusculoskeletal DiseasesCrystal Arthropathies

Study Officials

  • Claudio Rosso, Prof. Dr. med.

    Arthro Medics AG

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudio Rosso, PD Dr. med

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 25, 2020

First Posted

August 28, 2020

Study Start

November 22, 2016

Primary Completion

August 30, 2024

Study Completion

August 30, 2025

Last Updated

July 31, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)