Total Hip ReplacementNCT02850575

Bone Fixation of Mpact Double Mobility Cup

An observational study of Total Hip Replacement, run by Medacta International SA at 2 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial summary

This study aims to evaluate long term fixation of the Mpact Double Mobility cup trough IMAGIKA technology. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Total Hip Replacement
What is being tested?: Mpact Double Mobility cup
Type of treatment: Medical device
How many people: 150 participants
Where: 2 sitesFrance
Study dates: Jan 2014to Jan 2030
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

2 sites in 1 country.

France2 sites

Clinique Générale
Annecy, France, 74000
Orthéo - Espace Fauriel
Saint-Etienne, France, 42100

Other trials in France

About this study

Official title: Etude Prospective, Multicentrique, Non contrôlée, Non randomisée, Ouverte Pour l'évaluation de la Fixation Osseuse d'Une Cupule hémisphérique, le Mpact® Double Mobilité

This study aims to evaluate long term fixation of the Mpact Double Mobility cup trough IMAGIKA technology.

Conditions: Total Hip Replacement
Being tested: Mpact Double Mobility cup

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mpact Double Mobility cupDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

implant fixation trough IMAGIKA
implant fixation trough IMAGIKA
Measured: 10 years

Secondary outcomes (6)

Harris Hip Score
Harris Hip Score
Measured: preop, 3 months, 1, 2, 5, 10 years
complications
complications
Measured: intraop, immediate postop, 3 months, 1, 2, 5, 10 years
penetration of femoral head in the polyethylene insert trough IMAGIKA
penetration of femoral head in the polyethylene insert trough IMAGIKA
Measured: 3 months, 5 and 10 years
implant stability trough standard x-ray
implant stability trough standard x-ray
Measured: 3 months, 1, 2, 5, 10 years
implant survival trough Kaplan-Meier curve
implant survival trough Kaplan-Meier curve
Measured: 3 months, 1, 2, 5, 10 years
implant fixation trough IMAGIKA
implant fixation trough IMAGIKA
Measured: 3 months and 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Jan 2030

First posted1 Aug 2016 (estimated)
Study startJan 2014
Primary completionJan 2030 (estimated)
Study completionJan 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Total Hip ReplacementStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 150 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02850575
Sponsor's protocol ID: P01.017.01
Status last verified: Sep 2026
First submitted: 22 Jul 2016
Last updated: 8 Oct 2026
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Posterior Pericapsular Deep-gluteal Block
Pain, Postoperative
Enrolling by invitationPhase 2
Efficacy of Intravenous Oxytocin to Speed Recovery After THA
Total Hip Arthroplasty
Recruiting
FRONT Block for Quality of Recovery After Total Hip Arthroplasty
Osteoarthritis of the Hip, Postoperative Pain
RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
RecruitingPhase 4
Low-Volume Pericapsular Nerve Group (PENG) Block With Dexamethasone vs Standard-Volume PENG Block After Total Hip Arthroplasty
Pain, Postoperative, Muscle Weakness

All Total Hip Replacement trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Etude Prospective, Multicentrique, Non contrôlée, Non randomisée, Ouverte Pour l'évaluation de la Fixation Osseuse d'Une Cupule hémisphérique, le Mpact® Double Mobilité
ClinicalTrials.gov ID: NCT02850575
Acronym / sponsor ID: P01.017.01
Conditions: Total Hip Replacement
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 150 participants (estimated)
Lead sponsor: Medacta International SAIndustry (pharma, biotech, devices)
Study start: Jan 2014
Primary completion: Jan 2030 (estimated)
Study completion: Jan 2030 (estimated)
First posted: 1 Aug 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study aims to evaluate long term fixation of the Mpact Double Mobility cup trough IMAGIKA technology.

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All patients eligible for a total hip replacement at the investigational sites will be invited in the study

Key inclusion criteria (3 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mpact Double Mobility cup	Device	–

Primary outcome

implant fixation trough IMAGIKA
Time frame: 10 years
implant fixation trough IMAGIKA

6 secondary outcomes

Harris Hip Score
Time frame: preop, 3 months, 1, 2, 5, 10 years
complications
Time frame: intraop, immediate postop, 3 months, 1, 2, 5, 10 years
penetration of femoral head in the polyethylene insert trough IMAGIKA
Time frame: 3 months, 5 and 10 years
implant stability trough standard x-ray
Time frame: 3 months, 1, 2, 5, 10 years
implant survival trough Kaplan-Meier curve
Time frame: 3 months, 1, 2, 5, 10 years
implant fixation trough IMAGIKA
Time frame: 3 months and 5 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.

Related trials for Total Hip Replacement

Not yet recruiting
Posterior Pericapsular Deep-gluteal Block
Pain, Postoperative
Enrolling by invitationPhase 2
Efficacy of Intravenous Oxytocin to Speed Recovery After THA
Total Hip Arthroplasty
Recruiting
FRONT Block for Quality of Recovery After Total Hip Arthroplasty
Osteoarthritis of the Hip, Postoperative Pain
RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
RecruitingPhase 4
Low-Volume Pericapsular Nerve Group (PENG) Block With Dexamethasone vs Standard-Volume PENG Block After Total Hip Arthroplasty
Pain, Postoperative, Muscle Weakness

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Total Hip Replacement, run by Medacta International SA at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

implant fixation trough IMAGIKA (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02850575.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.