NCT02846636

Brief Summary

The main objective of this study is to evaluate the 10 year performances of Mpact cup in total hip arthroplasty.

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
36mo left

Started Aug 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Aug 2014Apr 2029

Study Start

First participant enrolled

August 1, 2014

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
12.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

14.7 years

First QC Date

July 22, 2016

Last Update Submit

September 23, 2025

Conditions

Total Hip Replacement

Outcome Measures

Primary Outcomes (1)

  • implant survival trough Kaplan-Meier curve

    10 years

Secondary Outcomes (3)

  • hip function with Harris Hip Score

    preop, 3/6 months, 1, 3, 5, 7, 10 years

  • record of adverse events

    intraop, 3/6 months, 1, 3, 5, 7, 10 years

  • implant stability trough assessment of presence of radiolucencies

    3/6 months, 1, 3, 5, 7, 10 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients eligible for total hip arthroplasty who meet the inclusion criteria will be invited in the study

You may qualify if:

  • patients requiring a total hip replacement who meets the standard indications for use for Medacta implants
  • patients who accept to participate in the study
  • patients who signed the consent form for the treatment of personal data

You may not qualify if:

  • patients presenting conditions identified as contraindication for Medacta implants
  • revision surgeries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Médico-Chirurgicale Paris V

Paris, France, 75007, France

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2016

First Posted

July 27, 2016

Study Start

August 1, 2014

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)