Total Hip ReplacementNCT02846636
Mpact Cup Performance After Total Hip Arthroplasty
An observational study of Total Hip Replacement, run by Medacta International SA at 1 site in France.
Trial summary
The main objective of this study is to evaluate the 10 year performances of Mpact cup in total hip arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Replacement
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2014to Apr 2029
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients eligible for total hip arthroplasty who meet the inclusion criteria will be invited in the study
Who may be able to join
- 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
Who cannot join
- patients presenting conditions identified as contraindication for Medacta implants
- revision surgeries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Multicentric, Non-controlled, Non-randomized Clinical Survey to Evaluate Mpact Cup Performance After Total Hip Arthroplasty
The main objective of this study is to evaluate the 10 year performances of Mpact cup in total hip arthroplasty.
- Conditions
- Total Hip Replacement
What is being measured
The primary outcome is the main question the study is designed to answer.
implant survival trough Kaplan-Meier curve
Measured: 10 years
Secondary outcomes (3)
hip function with Harris Hip Score
Measured: preop, 3/6 months, 1, 3, 5, 7, 10 years
record of adverse events
Measured: intraop, 3/6 months, 1, 3, 5, 7, 10 years
implant stability trough assessment of presence of radiolucencies
Measured: 3/6 months, 1, 3, 5, 7, 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startAug 2014
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Why it stopped: Surgeon stopped
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
- 100 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
- NCT02846636
- Sponsor's protocol ID
- P01.014.07
- Status last verified
- Sep 2026
- First submitted
- 22 Jul 2016
- Last updated
- 8 Oct 2026
- Results posted
- No
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
- Prospective, Multicentric, Non-controlled, Non-randomized Clinical Survey to Evaluate Mpact Cup Performance After Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02846636
- Acronym / sponsor ID
- P01.014.07
- Conditions
- Total Hip Replacement
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Surgeon stopped
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 27 Jul 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.
The main objective of this study is to evaluate the 10 year performances of Mpact cup in total hip arthroplasty.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients eligible for total hip arthroplasty who meet the inclusion criteria will be invited in the study
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- patients presenting conditions identified as contraindication for Medacta implants
- revision surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
implant survival trough Kaplan-Meier curve
Time frame: 10 years
3 secondary outcomes
hip function with Harris Hip Score
Time frame: preop, 3/6 months, 1, 3, 5, 7, 10 years
record of adverse events
Time frame: intraop, 3/6 months, 1, 3, 5, 7, 10 years
implant stability trough assessment of presence of radiolucencies
Time frame: 3/6 months, 1, 3, 5, 7, 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
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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.
1 site 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 1 site 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 2 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: paused, 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 1 site 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?
Results are not available in the source record.
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 survival trough Kaplan-Meier curve (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.