NCT04529798

Unknown

Clinical Study Evaluating Outcomes of Reverse Shoulder Arthr...

Arthro Medics AG Source

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Other study identifiers

Sponsor study identifier

S-35

Study Type

observational

Estimated enrollment

60

Locations

1 country

Sites

1

Timeline

Study Start

November 22, 2016

Actual (reported)

Primary Completion

August 30, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

August 30, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 60 participants
Study completion date: August 30, 2025
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
November 22, 2016
Actual (reported)
First Submitted
August 25, 2020
Actual (reported)
First Posted
August 28, 2020
Actual (reported)
Primary Completion
August 30, 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 30, 2025
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: July 31, 2024
Status Verified: July 2024
Last Update Submitted: July 30, 2024

Conditions

Osteo Arthritis Shoulders Rotator Cuff Tear Arthropathy

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

Sponsors & Collaborators

Arthro Medics AG
Otherlead

Study Sites (1)

Arthro Medics AG

Basel, Canton of Basel-City, 4054, Switzerland

RECRUITING

Claudio Rosso, PD Dr. med.CONTACT+41 61 301 26 26 c.rosso@arthro.ch

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 26 c.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

Actual (reported)

Primary Completion

August 30, 2024

Estimated (date passed)

NCT02512536

Does Botulinum A Toxin Help With Pain From Rotator Cuff Arthropathy?

Phase 2Completed

NCT02588027

Effect of Ibuprofen on Postoperative Opiate Medication Use and Shoulder Functional Outcomes

Not ApplicableCompleted

NCT03782675

Air Barrier System for the Reduction of Airborne Colony-forming Units During Total Shoulder Arthroplasty

Not ApplicableUnknown

NCT03580148

BMA vs Cortisone for Glenohumeral Osteoarthritis

Phase 2/3Completed

NCT05438914

Subscapularis Repair in Reverse Shoulder Arthroplasty

Not ApplicableUnknown

NCT04645329

Immobilization in Reverse Shoulder Prosthesis

Not ApplicableUnknown

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.

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

August 30, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

July 31, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04529798
Data provider: ClinicalTrials.gov
Source updated: 2024-07-31
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:27:46 UTC

Locations

CH(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations