Clinical Study Evaluating Outcomes of Reverse Shoulder Ar... | NCT04529798

Studies
Clinical Study Evaluating Outcomes of Reverse Shoulder Arthroplasty With SMR Stemless

NCT04529798

Sponsor

Arthro Medics AG

Status

Recruiting

Last Update Posted

Jul 31, 2024Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Rotator Cuff Tear Arthropathy
Osteo Arthritis Shoulders

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 22, 2016Actual

Primary Completion Date

Aug 30, 2024Estimated

Completion Date

Aug 30, 2025Estimated

First Submitted Date

Aug 25, 2020

First Submission Date that Met QC Criteria

Aug 25, 2020

First Posted Date

Aug 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2024

Last Update Posted Date

Jul 31, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Claudio Rosso, PD Dr. med	Contact	+41 61 301 26 26		c.rosso@arthro.ch

Overall Officials

Name	Affiliation	Role
Claudio Rosso, Prof. Dr. med.	Arthro Medics AG	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arthro Medics AG	Recruiting	Basel	Canton of Basel-City	4054	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000070656	Rotator Cuff Tear Arthropathy

Ancestor Terms

ID	Term
D002805	Chondrocalcinosis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided