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.
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
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
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- 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
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.
- 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)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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