Bone Fixation of Mpact Double Mobility Cup | NCT02850575

Studies
Bone Fixation of Mpact Double Mobility Cup

NCT02850575

Sponsor

Medacta International SA

Status

Active, not recruiting

Last Update Posted

Sep 29, 2025Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Total Hip Replacement

Interventions

Mpact Double Mobility cup

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

Sep 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

Jan 2014

Primary Completion Date

Jan 2030Estimated

Completion Date

Jan 2030Estimated

First Submitted Date

Jul 22, 2016

First Submission Date that Met QC Criteria

Jul 29, 2016

First Posted Date

Aug 1, 2016Estimated

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

Not provided

Is FDA Regulated Device

Not provided

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

150Estimated

Name	Type	Description	Arm Group Labels	Other Names
Mpact Double Mobility cup	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
implant fixation trough IMAGIKA	implant fixation trough IMAGIKA	10 years

Secondary Outcomes

Measure	Description	Time Frame
Harris Hip Score	Harris Hip Score	preop, 3 months, 1, 2, 5, 10 years
complications	complications	intraop, immediate postop, 3 months, 1, 2, 5, 10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

primary hip replacement
patients 18 to 80 years old
patients who accept the follow-up schedule

Exclusion Criteria:

femoral neck fracture
patients requiring grafts
progressive local or systemic infections
patients presenting muscular deficiency, neuromuscular disease or vascular insufficiency of the involved limb
patients suffering from diseases that can compromize the recovery to independent mobility
patients with BMI > 40
patients with cognitive diseases that can compromize their participation in the study
patients living in geographical area not allowing the clinical follow-up to be performed
patients participating in other biomedical research
patients <18 years old
patients > 80 years old
pregnant or breast feeding women

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

All patients eligible for a total hip replacement at the investigational sites will be invited in the study

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinique Générale		Annecy	France	74000	France
Orthéo - Espace Fauriel

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