Total Hip ArthroplastyNCT05818891
Multicenter Mpact DM France
An observational study of Total Hip Arthroplasty and Survival, Prosthesis, run by Medacta International SA at 1 site in France.
Trial summary
The primary objective of the study is to evaluate the 10-year performance of the MPACT DM cup in the treatment of patients requiring total hip arthroplasty. The primary endpoint is the 10-year life span of the prosthesis according to the Kaplan Meier curve. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Total Hip Arthroplasty, Survival, Prosthesis
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 5 Apr 2018to Apr 2031
- 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: The total number of patients needed for this study is 600. All patients with a condition requiring hip joint replacement will be invited to participate in the study by the investigator during consultations.
Who may be able to join
- Patient with a disease that meets the indications for use of Medacta implants (according to the instructions for use)
- Patient eligible for first-line total hip replacement
- Patient between 18 and 80 years of age
- Patient covered by the Social Security system or an equivalent protection plan
- Patient who is capable, in the opinion of the investigator, of fulfilling the requirements of the study
Who cannot join
- Patient requiring a transplant
- Patient with progressive local or systemic infection
- Patient with muscle loss, neuromuscular disease, or vascular impairment of the affected limb making surgery unwarranted
- Patient with known medical problems that may compromise independent recovery of mobility
- Patient with a BMI greater than 40 kg/m².
- Patient with major cognitive problems that do not allow a good understanding of the study requirements
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- Patient living in a geographical area that does not allow the study follow-up
- Patient participating in interventional research.
- Minor patient
- Protected adult patient
- Vulnerable person according to article L1121-6 of the Public Health Code
- Pregnant or nursing woman.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Orthopédique Médico-Chirurgical de Dracy Le Fort
Dracy-le-Fort
Philippe DEROCHE
About this study
Official title: Prospective, Multicenter, Non-Controlled, Non-Randomized, Open-Label Study To Evaluate The Efficacy And Performance Of The Mpact® Dual Mobility Hemispheric Cup
The primary objective of the study is to evaluate the 10-year performance of the MPACT DM cup in the treatment of patients requiring total hip arthroplasty.
The primary endpoint is the 10-year life span of the prosthesis according to the Kaplan Meier curve.
Read the detailed description
The primary objective of the study is to evaluate the 10-year performance of the MPACT DM cup in the treatment of patients requiring total hip arthroplasty evaluated through the Kaplan Meier curve.
The secondary objectives of the study are:
- To assess the function of the operated hip
- Evaluate the safety of the implant
- Evaluate the stability of the prosthetic components
Secondary endpoints were:
- Harris Hip Score The Harris Hip Score (HHS) items include an analysis of the operated hip according to pain, function, mobility and stability and a deformity analysis. The Harris Hip Score will be used to assess the patient's subjective and objective improvement in the above criteria.
- Evaluation of standard radiographs from the front and side. Periprosthetic edging and osteolysis will be evaluated using Delee and Charnley zones for the acetabular component and Gruen zones for the femoral component.
- Evaluation of implant stability and fit using the ARA score. This score is used to determine whether the implant causes changes in the surrounding bone structures. If signs occur, they can be considered either as "neutral", showing a simple adaptation and not reducing the result, or as "negative" to varying degrees. The maximum ARA score is 6 points, negative points from 1 to 4 can be attributed for each of these "negative" signs.
The arithmetic summation of these "risk factors" will lead to a final "score", defining the adaptation of the prosthesis to the bone sleeve at the time the images are taken, and which may naturally vary with time, either positively, if the fixation, which was precarious at the time, stabilizes (secondary osteoinduction by Hydroxyapatite of initial fibrosis zones, for example), or negatively in the presence of an evolving destabilization (there is obviously no negative score). The approach is similar for the femur and for the acetabulum.
❖ Collection of intraoperative and postoperative complications. Complications, such as infection, loosening, deep vein thrombosis (DVT), fracture, as well as other unexpected complications, will be evaluated.
- Conditions
- Total Hip Arthroplasty, Survival, Prosthesis
- Medical subject headings
- Prosthesis Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the 10-year performance of the MPACT DM cup in the treatment of patients requiring total hip arthroplasty.
Analysis with Kaplan Meier curve considering the revisions of the implants
Measured: 10 years after the index surgery
Secondary outcomes (3)
Evaluate the function of the operated hip
Evaluation of the Harris Hip Score with the analysis of the operated hip for pain, function, mobility and stability and a deformity analysis.
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
Evaluation of standard radiographs from the front and side. Periprosthetic edging and osteolysis will be evaluated using Delee and Charnley zones for the acetabular component and Gruen zones for the femoral component.
Measured: pre-op, 3 months, 1 year, 3 years, 5 years and 10 years after the index surgery
To evaluate the safety of the implant
Collecting all the adverse events through time
Collection of intraoperative and postoperative complications. Complications, such as infection, loosening, deep vein thrombosis (DVT), fracture, as well as other unexpected complications, will be evaluated.
Measured: Intra-op, 3 months, 1 year, 3 years, 5 years and 10 years after the index surgery
To evaluate the stability of the prosthetic components
Evaluation of implant stability and fit using the ARA score. This score is used to determine whether the implant causes changes in the surrounding bone structures. If signs occur, they can be considered either as "neutral", showing a simple adaptation and not reducing the result, or as "negative" to varying degrees. The maximum ARA score is 6 points, negative points from 1 to 4 can be attributed for each of these "negative" signs.
The arithmetic summation of these "risk factors" will lead to a final "score", defining the adaptation of the prosthesis to the bone sleeve at the time the images are taken, and which may naturally vary with time, either positively, if the fixation, which was precarious at the time, stabilizes (secondary osteoinduction by Hydroxyapatite of initial fibrosis zones, for example), or negatively in the presence of an evolving destabilization (there is obviously no negative score). The approach is similar for the femur and for the acetabulum.
Measured: pre-op, 3 months, 1 year, 3 years, 5 years and 10 years after the index surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start5 Apr 2018
- Primary completionApr 2028 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ArthroplastyStudies 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe DEROCHE, Principal investigator, Centre Orthopédique Médico-Chirurgical de Dracy Le Fort
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818891
- Sponsor's protocol ID
- P01.017.03
- Status last verified
- Sep 2026
- First submitted
- 5 Apr 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No