Total Hip Arthroplasty (THA)NCT06748885
Mpact 3D Metal Monolit Study
An observational study of Total Hip Arthroplasty (THA), run by Medacta International SA at 3 sites in France.
Trial summary
Total hip arthroplasty (THA) is one of the most common operations performed in orthopaedics to improve a patient's quality of life. Surgeons are constantly seeking to improve all aspects of care related to this procedure, whether it be improving implant technology, improving instrumentation or the technique involved… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Total Hip Arthroplasty (THA)
- What is being tested?
- Mpact 3D Metal Monolith
- Type of treatment
- Medical device
- How many people
- 88 participants
- Where
- 3 sitesFrance
- Study dates
- 28 Feb 2024to Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who meet the inclusion criteria
Who may be able to join
- Patient with a disease that corresponds to the indications for use of Medacta implants (according to the instructions for use)
- Patient eligible for primary total hip arthroplasty
- Patient aged between 18 and 75 years
- Patient covered by the French Social Security system or an equivalent protection scheme.
- Patient able, in the investigator's opinion, to comply with the requirements of the study.
Who cannot join
- Patient suffering from inflammatory arthritis
- Previously operated hip
- Patient requiring a transplant
- Hip tumour involved
- Patient with progressive local or systemic infection
- Severe acetabular dysplasia
- Patient with muscle loss, neuromuscular disease or vascular impairment of the affected limb.
- 4. Patient with known medical problems that may compromise independent recovery of mobility 5. Patient with a BMI greater than 40 kg/m². 6. Patient with major cognitive impairment that prevents him/her from fully understanding the requirements of the study 7. Patient living in a geographical area where study follow-up is not possible. 8. Patient taking part in interventional research 9. Minor patient 10. Protected adult patient 11. Vulnerable person according to article L1121-6 of the Public Health Code
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Not yet recruiting
Clinique Brétéché
Nantes, 44000
Kamel Ajouy, 02 51 86 78 50, kamajouy@yahoo.fr
- Not yet recruiting
Hôpital Lariboisière
Paris, 75010
Pascal Bizot, 01 49 95 91 38, pascal.bizot@aphp.fr
- Recruiting
Hôpital Cochin
Paris, 75014
Philippe Anract, 01 58 41 30 38, philippe.anract@aphp.fr
About this study
Official title: Prospective, Multicentre, Non-randomised, Open Study Evaluating the Efficacy and Fixation of the Mpact 3D Metal Monolit Cup
Total hip arthroplasty (THA) is one of the most common operations performed in orthopaedics to improve a patient's quality of life.
Surgeons are constantly seeking to improve all aspects of care related to this procedure, whether it be improving implant technology, improving instrumentation or the technique involved in performing the procedure.
Read more
In recent years, a new porous titanium coating has been introduced to promote good osseointegration of uncemented cups. High friction torque and a feeling of immediate anchorage provide excellent primary stability, while high porosity ensures bone growth providing secondary stability. With higher porosity than standard coatings, a greater volume of bone can be present in the porous surface, giving a proportional increase in force at the interface. he Mpact 3D Metal Monolith cup has been designed to provide greater range of motion and improved joint stability, with a reduced risk of dislocation. It is an innovative design that improves stability and provides a favourable environment for long-term biological metal-bone fixation.
The current study aims to collect clinical and radiological data to assess the function of the operated hip and the stability of the Mpact 3D Metal Monolith cup at 2 years and survival at 5 years for the treatment of patients requiring hip arthroplasty.
- Conditions
- Total Hip Arthroplasty (THA)
- Being tested
- Mpact 3D Metal Monolith
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mpact 3D Metal MonolithDevice
THA with Mpact 3D Metal Monolith
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the hip function
The Harris Hip Scale (HHS) was developed for the assessment of the results of hip surgery, and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The original version was published 1969[1]. The HHS is an outcome measure administered by a qualified health care professional, such as a physician or a physical therapist. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. Results can be recorded and calculated online. The maximum score possible is 100. Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.
Measured: Preoperative, 3 months, 6 months, 1 year, 2 years, 5 years
Secondary outcomes (6)
Analysis of the primary stability of the implant at 2 years
Protocol EBRA-Cup: Measurement of longitudinal/transversal migration of acetabular cup in digital serial radiographs (minimum of 4 x-rays per series). Full size AP pelvis radiographs are required.
Accuracy: +/- 1mm.
Measured: 2 years
Analysis of the wear of the polyethylene insert (HighCross) at 2 years
Martell method of linear wear measurement
Measured: 2 years
Evaluation of the fixation and osteolysis
Radiological analysis
Measured: Immediate postoperative, 3 months, 6 months, 1 year, 2 years, 5 years
Evaluation of the mobility
The Oxford Hip Score (OHS) is a joint-specific, patient-reported outcome measure designed to assess disability in patients undergoing total hip replacement. The OHS is a short 12-item survey that can be done with pen and paper. Patients are asked to reflect on their pain and functional ability over the previous four weeks. There are two domains (pain and function) with six items or questions in each. Each item has five possible responses. In the original scoring responses were from 1 = least difficult to 5= most difficult. Item scores are summed to give a total score from anywhere between 12 and 60. The lower the score, the better the outcome.
Measured: Preoperative, 3 months, 6 months, 1 year, 2 years, 5 years
Evaluation of the safety of the implant
Collection of intraoperative and postoperative complications
Measured: Intraoperative, immediate postoperative, 3 months, 6 months, 1 year, 2 years, 5 years
Evaluation of the survival of the implant
Kaplan-Meier survival method
Measured: 3 months, 6 months, 1 year, 2 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start28 Feb 2024
- Primary completionDec 2030 (estimated)
- Study completionDec 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 Arthroplasty (THA)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 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
- NCT06748885
- Sponsor's protocol ID
- P01.028.01
- Status last verified
- Oct 2026
- First submitted
- 16 Dec 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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, Multicentre, Non-randomised, Open Study Evaluating the Efficacy and Fixation of the Mpact 3D Metal Monolit Cup
- ClinicalTrials.gov ID
- NCT06748885
- Acronym / sponsor ID
- P01.028.01
- Conditions
- Total Hip Arthroplasty (THA)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 27 Dec 2024 (actual)
- 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.
Total hip arthroplasty (THA) is one of the most common operations performed in orthopaedics to improve a patient's quality of life.
Surgeons are constantly seeking to improve all aspects of care related to this procedure, whether it be improving implant technology, improving instrumentation or the technique involved in performing the procedure.
In recent years, a new porous titanium coating has been introduced to promote good osseointegration of uncemented cups. High friction torque and a feeling of immediate anchorage provide excellent primary stability, while high porosity ensures bone growth providing secondary stability. With higher porosity than standard coatings, a greater volume of bone can be present in the porous surface, giving a proportional increase in force at the interface. he Mpact 3D Metal Monolith cup has been designed to provide greater range of motion and improved joint stability, with a reduced risk of dislocation. It is an innovative design that improves stability and provides a favourable environment for long-term biological metal-bone fixation.
The current study aims to collect clinical and radiological data to assess the function of the operated hip and the stability of the Mpact 3D Metal Monolith cup at 2 years and survival at 5 years for the treatment of patients requiring hip arthroplasty.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who meet the inclusion criteria
Key inclusion criteria (5 listed)
- Patient with a disease that corresponds to the indications for use of Medacta implants (according to the instructions for use)
- Patient eligible for primary total hip arthroplasty
- Patient aged between 18 and 75 years
- Patient covered by the French Social Security system or an equivalent protection scheme.
- Patient able, in the investigator's opinion, to comply with the requirements of the study.
Key exclusion criteria (8 listed)
- Patient suffering from inflammatory arthritis
- Previously operated hip
- Patient requiring a transplant
- Hip tumour involved
- Patient with progressive local or systemic infection
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 3D Metal MonolithTHA with Mpact 3D Metal Monolith | Device | – |
Primary outcome
Evaluation of the hip function
Time frame: Preoperative, 3 months, 6 months, 1 year, 2 years, 5 years
The Harris Hip Scale (HHS) was developed for the assessment of the results of hip surgery, and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The original version was published 1969[1]. The HHS is an outcome measure administered by a qualified health care professional, such as a physician or a physical therapist. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. Results can be recorded and calculated online. The maximum score possible is 100. Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.
6 secondary outcomes
Analysis of the primary stability of the implant at 2 years
Time frame: 2 years
Analysis of the wear of the polyethylene insert (HighCross) at 2 years
Time frame: 2 years
Evaluation of the fixation and osteolysis
Time frame: Immediate postoperative, 3 months, 6 months, 1 year, 2 years, 5 years
Evaluation of the mobility
Time frame: Preoperative, 3 months, 6 months, 1 year, 2 years, 5 years
Evaluation of the safety of the implant
Time frame: Intraoperative, immediate postoperative, 3 months, 6 months, 1 year, 2 years, 5 years
Evaluation of the survival of the implant
Time frame: 3 months, 6 months, 1 year, 2 years, 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.
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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.
3 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 Arthroplasty (THA), run by Medacta International SA at 3 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 5 inclusion and 8 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: looking for participants now, 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 3 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?
Contact Philippe Anract (01 58 41 30 38, philippe.anract@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the hip function (time frame: Preoperative, 3 months, 6 months, 1 year, 2 years, 5 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; AzTrials last refreshed its copy on 27 Oct 2026.