Multicenter Mpact DM France

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.

Study Overview

• Status: Recruiting
• Conditions: Total Hip Arthroplasty; Survival, Prosthesis

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.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Arianna Girardi; Phone Number: +41 91 696 60 60; Email: girardi@medacta.ch

Study Locations

• France
  • Dracy-le-Fort, France
    • Recruiting
    • Centre Orthopédique Médico-Chirurgical de Dracy Le Fort
    • Contact: Philippe DEROCHE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

1. Patient with a disease that meets the indications for use of Medacta implants (according to the instructions for use)
2. Patient eligible for first-line total hip replacement
3. Patient between 18 and 80 years of age
4. Patient covered by the Social Security system or an equivalent protection plan
5. Patient who is capable, in the opinion of the investigator, of fulfilling the requirements of the study

Exclusion Criteria:

1. Patient requiring a transplant
2. Patient with progressive local or systemic infection
3. Patient with muscle loss, neuromuscular disease, or vascular impairment of the affected limb making surgery unwarranted
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 problems that do not allow a good understanding of the study requirements
7. Patient living in a geographical area that does not allow the study follow-up
8. Patient participating in interventional research.
9. Minor patient
10. Protected adult patient
11. Vulnerable person according to article L1121-6 of the Public Health Code
12. Pregnant or nursing woman.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	10 years after the index surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	pre-op, 3 months, 1 year, 3 years, 5 years and 10 years after the index surgery

Collaborators and Investigators

• Sponsor: Medacta International SA
• Investigators: Principal Investigator: Philippe DEROCHE, Centre Orthopédique Médico-Chirurgical de Dracy Le Fort

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2018
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2031

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Prosthesis Failure
• Other Study ID Numbers: P01.017.03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No