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NCT Number: NCT05818891

Multicenter Mpact DM France

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Orthopédique Médico-Chirurgical de Dracy Le Fort

Dracy-le-Fort, France

Location status: Recruiting

Location contact

Philippe DEROCHE

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

Primary outcomes

  1. Evaluate the 10-year performance of the MPACT DM cup in the treatment of patients requiring total hip arthroplasty.

    Time frame: 10 years after the index surgery

    Analysis with Kaplan Meier curve considering the revisions of the implants

Secondary outcomes

  1. Evaluate the function of the operated hip

    Time frame: pre-op, 3 months, 1 year, 3 years, 5 years and 10 years after the index surgery

    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.

  2. To evaluate the safety of the implant

    Time frame: Intra-op, 3 months, 1 year, 3 years, 5 years and 10 years after the index surgery

    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.

  3. To evaluate the stability of the prosthetic components

    Time frame: pre-op, 3 months, 1 year, 3 years, 5 years and 10 years after the index surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Arianna Girardi

CONTACT

[email protected]

+41 91 696 60 60

Sponsors and collaborators

Lead sponsor

Medacta International SA

Industry

Registry information

Official study title

Prospective, Multicenter, Non-Controlled, Non-Randomized, Open-Label Study To Evaluate The Efficacy And Performance Of The Mpact® Dual Mobility Hemispheric Cup

Important dates

Study start
2018
Primary completion
2028
Study completion
2031
First posted
Apr 19, 2023
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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