The Medacta International AMIStem-P Post-Marketing Survei... | NCT04997005

Studies
The Medacta International AMIStem-P Post-Marketing Surveillance Study

NCT04997005

Sponsor

Medacta International SA

Status

Active, not recruiting

Last Update Posted

May 8, 2025Actual

Enrollment

550Estimated

Phase

Not provided

Conditions

Arthrosis
Traumatic Arthritis
Rheumatoid Polyarthritis
Congenital Hip Dysplasia
Avascular Necrosis of the Femoral Head

Interventions

AMIStem-P

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

May 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 26, 2019Actual

Primary Completion Date

Apr 30, 2029Estimated

Completion Date

Dec 31, 2032Estimated

First Submitted Date

Aug 4, 2021

First Submission Date that Met QC Criteria

Aug 4, 2021

First Posted Date

Aug 9, 2021Actual

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

May 5, 2025

Last Update Posted Date

May 8, 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

Not provided

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

550Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AMIStem-P	Device	Performance of Total Hip Arthroplasty (THA) with AMIStem-P femoral stem implant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival rate	Kaplan Meier method	10 years

Secondary Outcomes

Measure	Description	Time Frame
Harris Hip Score	Harris Hip Score [min = 0 (worst clinical outcome), max = 100 (best clinical outcome)]	3/6 months, 1, 3, 5 and 10 years
Oxford Hip Score	Oxford Hip Score [min = 0 (worst functional outcome), max = 48 (best functional outcome)]

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with a disease (primary coxarthrosis, inflammatory arthritis of the hip, necrosis of the femoral head, etc.) requiring a total hip replacement
Patient eligible to receive an uncemented AMIStem-P femoral stem
Patient agreeing to comply with the study requirements
Patient willing to provide written informed consent
Patient affiliated to a social security system
Patients between 18 and 85 years old

Exclusion Criteria:

Participation in biomedical research
Patients younger than 18 years old
Vulnerable adult patients according to article L1121-6 of the French Public Health Code
Pregnant or breastfeeding women
Patients unable to provide written informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients requiring Total Hip Arthroplasty and who are suitable to receive Medacta AMIStem-P femoral stem will be proposed to take part to the current post-market surveillance study during their pre-operative visit.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexandru Nebunescu-Schirliu, MD	Hôpital Jacques-Puel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinique de Saint Omer		Blendecques		62575	France
Hôpital Castres

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis
D006618	Hip Dislocation, Congenital
D005271	Femur Head Necrosis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided