Multicenter Mpact DM France

NCT05818891 | Recruiting

• 1 other identifier: P01.017.03
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Total Hip Arthroplasty; Survival, Prosthesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Evaluate the function of the operated hip

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

• To evaluate the safety of the implant

  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

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medacta International SA: lead

Study Sites (1)

Centre Orthopédique Médico-Chirurgical de Dracy Le Fort

Dracy-le-Fort, France

RECRUITING

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Philippe DEROCHE

  Centre Orthopédique Médico-Chirurgical de Dracy Le Fort

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arianna Girardi

CONTACT

+41 91 696 60 60; girardi@medacta.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: April 19, 2023
• Study Start: April 5, 2018
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2031
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)