Clinical and Radiological Outcomes of Medacta Shoulder Sy... | NCT05926622

Studies
Clinical and Radiological Outcomes of Medacta Shoulder System FR

NCT05926622

Sponsor

Medacta International SA

Status

Recruiting

Last Update Posted

Sep 29, 2025Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Primary Osteoarthritis
Secondary Osteoarthritis
Rotator Cuff Tear Arthropathy
Rheumatoid Arthritis Shoulder
Avascular Necrosis
Fracture
Revision of Shoulder Arthroplasty

Interventions

Not provided

Countries

France

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

Jun 2025

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

Mar 15, 2022Actual

Primary Completion Date

Mar 2032Estimated

Completion Date

Mar 2037Estimated

First Submitted Date

Jun 22, 2023

First Submission Date that Met QC Criteria

Jun 22, 2023

First Posted Date

Jul 3, 2023Actual

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

Sep 23, 2025

Last Update Posted Date

Sep 29, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

FDAAA801 Violation

Not provided

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

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival Rate	Kaplan Meier method	10 years

Secondary Outcomes

Measure	Description	Time Frame
Clinical outcome evaluating Constant & Murley Score	Constant & Murley Score (CMS): The CMS is a multi-item functional scale assessing pain, ADL, ROM and strength of the affected shoulder. Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively	1, 2, 5 and 10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients older than 18 years
Patient with one of the following diagnosis:

Primary osteoarthritis Secondary osteoarthritis Cuff tear arthropathy; insufficient rotator cuff Acute fracture (<21d) Rheumatoid or inflammatory arthritis Avascular necrosis Other posttraumatic condition Revision of shoulder arthroplasty

Exclusion Criteria:

Patients with malignant diseases (at the time of surgery)
Patients with proven or suspect infections (at the time of surgery)
Patients with functional deficits other than dysfunction of the shoulder (at the time of surgery)
Patients with known incompatibility or allergy to products materials (at the time of surgery)

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

Patients requiring TSA and who are suitable to receive Medacta Shoulder System will be proposed to take part to the current post-marketing surveillance study during their pre-operative visit.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Arianna Girardi	Contact	+41 91 696 60 60		girardi@medacta.ch

Overall Officials

Name	Affiliation	Role
Bruno Toussaint	Clinique Générale Annecy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinique Générale Annecy	Recruiting	Annecy		74000	France

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
D010020	Osteonecrosis
D050723	Fractures, Bone

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided