Multicenter Mpact DM France

Medacta

Status: Enrolling

Conditions: Survival, Prosthesis; Total Hip Arthroplasty

Study type: Observational

Funder types: Industry

Identifiers

NCT05818891

P01.017.03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.